ZE FANG TECHNOLOGY CO., LTD.

FDA Device Registration & Listing · Taichung, TW · Registration 3013689189

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013689189
FEI Number
3013689189
Entity Name
ZE FANG TECHNOLOGY CO., LTD.
City/State/Country
Taichung, TW
Establishment Address
1F, No.17, Aly. 81, Ln. 2, Sec.1 Zhongxing Rd., Dali Dist., Taichung Taichung - District, TAIWAN (CHINA) 412, Taichung 412, TW
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ZE FANG TECHNOLOGY CO., LTD. (Owner Number: 10062228)
Owner / Operator Contact Address
No.17, Aly. 81, Ln. 2, Sec.1 Zhongxing Rd., Dali Dist., Taichung Taichung - District, TAIWAN (CHINA) 412, Taichung, TW-TXG 412, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Function SLB-ROTH22 UL1 Function SLB-ROTH22 LR1 Classic Mini B.MBT18 (345H) 3D Self-ligating Bracket-M002223R Classic Mini B.MBT18 UR5(W/H) Function SLB-Standard22 UL3 Classic Mini B.MBT18 LR4(W/H) Classic Mini B.ROTH18 LR2(W/O) Function SLB-MBT18 LR4 Classic Mini B.MBT18 UR2(W/O) Classic Mini B.MBT22 UR4(W/H) Classic Mini B.MBT22 LR1(W/O) 3D Self-ligating Bracket-M002215R Function SLB-Standard22 LL3 Function SLB-Standard22 LL5 3D Self-ligating Bracket-M002223S 3D Self-ligating Bracket-M002214M Function SLB-ROTH18 LL4 3D Self-ligating Bracket-M002222L Function SLB-MBT18 LR1 3D Self-ligating Bracket-M002235S Function SLB-ROTH18 UL1 3D Self-ligating Bracket-M002232H 3D Self-ligating Bracket-M002245M Classic Mini B.MBT22 UL4(W/H) Function SLB-Low22 UR3 Function SLB-ROTH22 UR4 Function SLB-Standard22 LR3 Classic Mini B.MBT18 LR3(W/H) Function SLB-High22 UR5 3D Self-ligating Bracket-M002211L 3D Self-ligating Bracket-M002241M 3D Self-ligating Bracket-M002215L Function SLB-MBT22 LL4 3D Self-ligating Bracket-M002234L Function SLB-ROTH22 UL5 Classic Mini B.MBT18 UR1(W/O) Function SLB-Low22 LL1 3D Self-ligating Bracket-M002211H Function SLB-MBT18 UL5 Classic Mini B.ROTH22 UL1(W/O) Function SLB-ROTH18 UL5 Classic Mini B.ROTH22LL5(W/H) 3D Self-ligating Bracket-M002243S 3D Self-ligating Bracket-M002225M Classic Mini B.MBT18 LL5(W/H) Classic Mini B.ROTH18 LR1(W/O) Classic Mini B.ROTH18LR4(W/H) Function SLB-MBT22 LL1 Classic Mini B.ROTH18UL3(W/H) Classic Mini B.ROTH18LL4(W/H) 3D Self-ligating Bracket-M002221L Function SLB-High22 UL4 Power Button M (3.5MM_7) Classic Mini B.MBT18 LL1(W/O) Hook Button Function SLB-Low22 UL2 Function SLB-MBT22 LR1 Function SLB-MBT18 UL2 3D Self-ligating Bracket-M002232L 3D Self-ligating Bracket-M002245H Function SLB-MBT18 LL1 Function SLB-ROTH22 LR2 Function SLB-Low22 LL2 3D Self-ligating Bracket-M002225S 3D Self-ligating Bracket-M002242S Function SLB-Low22 LL5 3D Self-ligating Bracket-M002213M 3D Self-ligating Bracket-M002241R 3D Self-ligating Bracket-M002212 Function SLB-ROTH22 LR4 3D Self-ligating Bracket-M002245R Classic Mini B.MBT22 UR1(W/O) Function SLB-High22 UL1 Function SLB-Standard22 LR2 Function SLB-MBT22 UR1 Function SLB-ROTH18 LL3 Function SLB-High22 UR3 3D Self-ligating Bracket-M002222R 3D Self-ligating Bracket-M002211R Function SLB-MBT22 LL3 3D Self-ligating Bracket-M002234M Function SLB-Standard22 Function SLB-MBT22 UR2 3D Self-ligating Bracket-M002214S Classic Mini B.ROTH22 (345H) Classic Mini B.ROTH18 UR1(W/O) 3D Self-ligating Bracket-M002215 Classic Mini B.ROTH18 LL1(W/O) Classic Mini B.ROTH18LL5(W/H) 3D Self-ligating Bracket-M002212M 3D Self-ligating Bracket-M002242L Function SLB-MBT22 UR3 Function SLB-ROTH18 LL5 3D Self-ligating Bracket-M002222M 3D Self-ligating Bracket-M002211S 3D Self-ligating Bracket-M002243M 3D Self-ligating Bracket-M002232R Function SLB-ROTH18 LR2 3D Self-ligating Bracket-M002214L 3D Self-ligating Bracket-M002242R Function SLB-MBT22 UL5 3D Self-ligating Bracket-M002234 Function SLB-ROTH22 UL4 Function SLB-Low22 3D Self-ligating Bracket-M002225H Classic Mini B.MBT22 UL5(W/H) Classic Mini B.ROTH22 UR1(W/O) Function SLB-MBT18 UR2 Classic Mini B.ROTH22UL3(W/H) Classic Mini B.ROTH22LL4(W/H) Classic Mini B.MBT22 UR5(W/H) Classic Mini B.MBT18 LL3(W/H) 3D Self-ligating Bracket-M002223H Classic Mini B.MBT22 LL4(W/H) 3D Self-ligating Bracket-M002245 3D Self-ligating Bracket-M002242M Classic Mini B.MBT22 LR3(W/H) Function SLB-High22 UR4 Function SLB-High22 3D Self-ligating Bracket-M002215H Classic Mini B.ROTH18 UR2(W/O) 3D Self-ligating Bracket-M002214 Function SLB-Low22 UR5 Function SLB-MBT22 UR4 Function SLB-ROTH18 LR4 Classic Mini B.ROTH18UL4(W/H) Function SLB-Standard22 UL1 3D Self-ligating Bracket-M002225 3D Self-ligating Bracket-M002222H Function SLB-MBT22 UL1 Classic Mini B.ROTH22UL5(W/H) 3D Self-ligating Bracket-M002200H Function SLB-ROTH18 UL4 Function SLB-ROTH22 LL1 Function SLB-High22 LR5 Function SLB-High22 UL5 Function SLB-MBT18 LL2 Lingual Eyelet-Open Function SLB-MBT22 LR4 Classic Mini B.MBT18 LR2(W/O) Function SLB-Standard22 LR4 3D Self-ligating Bracket-M002200 3D Self-ligating Bracket-M002241L Function SLB-ROTH18 LR1 Classic Mini B.ROTH22UR5(W/H) Function SLB-ROTH22 UL2 Function SLB-ROTH18 LR3 Classic Mini B.MBT22 LL1(W/O) Function SLB-Low22 UR4 Function SLB-ROTH18 UR4 3D Self-ligating Bracket-M002244L Function SLB-MBT18 LR5 Function SLB-ROTH18 LL1 3D Self-ligating Bracket-M002213L 3D Self-ligating Bracket-M002232 3D Self-ligating Bracket-M002243R Function SLB-High22 LR1 3D Self-ligating Bracket-M002225L Function SLB-MBT18 UR4 3D Self-ligating Bracket-M002214R Function SLB-Low22 UL1 3D Self-ligating Bracket-M002235H 3D Self-ligating Bracket-M002200L Function SLB-Standard22 UR5 3D Self-ligating Bracket-M002213S 3D Self-ligating Bracket-M002215S Power Button S (3.5MM_6) Function SLB-Low22 UR2 Function SLB-ROTH22 LR5 Classic Mini B.ROTH22 LR2(W/O) Function SLB-ROTH18 UR2 3D Self-ligating Bracket-M002233H 3D Self-ligating Bracket-M002231R 3D Self-ligating Bracket-M002224L 3D Self-ligating Bracket-M002224M 3D Self-ligating Bracket-M002200S Function SLB-Low22 LR2 3D Self-ligating Bracket-M002234H Function SLB-MBT18 LL3 3D Self-ligating Bracket-M002244 3D Self-ligating Bracket-M002244M Classic Mini B.ROTH22LL3(W/H) Classic Mini B.MBT22 LR4(W/H) Function SLB-Low22 UL3 3D Self-ligating Bracket-M002224S Function SLB-Low22 LR4 Classic Mini B.ROTH22 LL2(W/O) Classic Mini B.MBT18 UL5(W/H) 3D Self-ligating Bracket-M002234R 3D Self-ligating Bracket-M002231M 3D Self-ligating Bracket-M002225R Function SLB-High22 LL1 Classic Mini B.MBT18 LR5(W/H) Classic Mini B.ROTH22UR4(W/H) Function SLB-ROTH18 UL2 Function SLB-Low22 LR1 Classic Mini B.ROTH22UL4(W/H) 3D Self-ligating Bracket-M002232S Classic Mini B.MBT22 UR3(W/H) Function SLB-Standard22 UL2 3D Self-ligating Bracket-M002224 Function SLB-Standard22 LR5 Classic Mini B.MBT22 LR2(W/O) Function SLB-Standard22 UR4 Function SLB-ROTH22 LL5 3D Self-ligating Bracket-M002221H Function SLB-MBT22 Function SLB-Standard22 LL1 3D Self-ligating Bracket-M002245L Classic Mini B.ROTH18LL3(W/H) 3D Self-ligating Bracket-M002214H Function SLB-ROTH22 UR1 3D Self-ligating Bracket-M002233M Function SLB-MBT22 UL2 3D Self-ligating Bracket-M002211M Classic Mini B.MBT18 UR3(W/H) Function SLB-High22 UR1 3D Self-ligating Bracket-M002243L Classic Mini B.ROTH18LR5(W/H) Function SLB-High22 LR3 Function SLB-ROTH18 LR5 Function SLB-MBT18 UR5 Lingual Buttons-M Function SLB-MBT18 UR3 3D Self-ligating Bracket-M002233S Classic Mini B.ROTH18 (345H) 3D Self-ligating Bracket-M002243H Function SLB-Low22 UL4 Function SLB-High22 UL3 Classic Mini B.ROTH22 UR2(W/O) Lingual Buttons-S Function SLB-High22 LL3 Function SLB-MBT18 Classic Mini B.MBT18 UL4(W/H) 3D Self-ligating Bracket-M002231S Function SLB-MBT18 UL4 Classic Mini B.ROTH18UR3(W/H) Classic Mini B.ROTH18UR4(W/H) Classic Mini B.MBT18 UR4(W/H) Function SLB-MBT18 LL4 3D Self-ligating Bracket-M002231 3D Self-ligating Bracket-M002211 Classic Mini B.MBT18 UL1(W/O) Classic Mini B.ROTH22LR5(W/H) 3D Self-ligating Bracket-M002244H 3D Self-ligating Bracket-M002223 Classic Mini B.MBT18 LR1(W/O) 3D Self-ligating Bracket-M002222S 3D Self-ligating Bracket-M002235R Function SLB Hook Function SLB-Low22 LR3 Function SLB-Standard22 LL2 Function SLB-Low22 UR1 Function SLB-High22 LL4 3D Self-ligating Bracket-M002242H Function SLB-ROTH18 UR3 Classic Mini B.ROTH22UR3(W/H) Function SLB-ROTH18 LL2 3D Self-ligating Bracket-M002213H Function SLB-ROTH22 LL2 Function SLB-MBT22 LL2 3D Self-ligating Bracket-M002241S 3D Self-ligating Bracket-M002232M 3D Self-ligating Bracket-M002221R Classic Mini B.MBT18 LL2(W/O) Classic Mini B.MBT22 UL2(W/O) Classic Mini B.ROTH18UR5(W/H) 3D Self-ligating Bracket-M002242 Function SLB-ROTH22 UR3 Classic Mini B.ROTH18UL5(W/H) Function SLB-Standard22 UR1 Function SLB-MBT22 LR2 Function SLB-ROTH18 UL3 3D Self-ligating Bracket-M002224R 3D Self-ligating Bracket-M002200R Classic Mini B.MBT22 (345H) 3D Self-ligating Bracket-M002223L 3D Self-ligating Bracket-M002223M Function SLB-Standard22 LR1 Function SLB-ROTH22 UR2 Function SLB-Standard22 UL5 3D Self-ligating Bracket-M002233L Function SLB-Standard22 UR3 Function SLB-MBT22 LR3 Function SLB-Low22 LR5 Function SLB-High22 LR4 Classic Mini B.MBT18 UL2(W/O) 3D Self-ligating Bracket-M002213 Classic Mini B.MBT22 LL3(W/H) Classic Mini B.ROTH22LR3(W/H) Function SLB-Low22 LL4 Function SLB-MBT18 UR1 Function SLB-ROTH22 UR5 3D Self-ligating Bracket-M002233R Function SLB-ROTH22 LL3 Function SLB-MBT22 LL5 Classic Mini B.MBT22 LL5(W/H) Classic Mini B.ROTH18 UL1(W/O) 3D Self-ligating Bracket-M002234S 3D Self-ligating Bracket-M002243 3D Self-ligating Bracket-M002231L Classic Mini B.MBT22 LL2(W/O) 3D Self-ligating Bracket-M002235M Function SLB-MBT18 LR3 Function SLB-MBT18 UL1 Function SLB Instrument Classic Mini B.ROTH22 LL1(W/O) 3D Self-ligating Bracket-M002221S Classic Mini B.MBT18 UL3(W/H) Function SLB-MBT22 LR5 3D Self-ligating Bracket-M002231H Function SLB-High22 LL2 Function SLB-MBT22 UL4 Function SLB-MBT22 UL3 3D Self-ligating Bracket-M002241H 3D Self-ligating Bracket-M002235 Classic Mini B.MBT22 UL3(W/H) Function SLB-MBT22 UR5 Lingual Eyelet-Closed 3D Self-ligating Bracket-M002212H Function SLB-Standard22 LL4 3D Self-ligating Bracket-M002241 Classic Mini B.MBT22 UL1(W/O) 3D Self-ligating Bracket-M002221 3D Self-ligating Bracket-M002224H Function SLB-Standard22 UR2 Function SLB-MBT18 LR2 3D Self-ligating Bracket-M002213R Function SLB-ROTH18 Function SLB-High22 LL5 Function SLB-Low22 LL3 3D Self-ligating Bracket-M002222 Function SLB-Standard22 UL4 3D Self-ligating Bracket-M002244S Classic Mini B.ROTH22 UL2(W/O) 3D Self-ligating Bracket-M002233 3D Self-ligating Bracket-M002215M Function SLB-ROTH22 UL3 Function SLB-ROTH22 LR3 Function SLB-High22 UL2 Function SLB-ROTH18 UR5 3D Self-ligating Bracket-M002212S Classic Mini B.MBT22 UR2(W/O) Classic Mini B.ROTH18LR3(W/H) 3D Self-ligating Bracket-M002235L 3D Self-ligating Bracket-M002200M Function SLB-Low22 UL5 Function SLB-MBT18 LL5 Classic Mini B.ROTH18 LL2(W/O) 3D Self-ligating Bracket-M002221M Classic Mini B.MBT18 LL4(W/H) 3D Self-ligating Bracket-M002212L Classic Mini B.ROTH18 UL2(W/O) Classic Mini B.MBT22 LR5(W/H) Classic Mini B.ROTH22 LR1(W/O) Function SLB-MBT18 UL3 Function SLB-ROTH22 LL4 Function SLB-ROTH18 UR1 Function SLB-High22 LR2 3D Self-ligating Bracket-M002245S 3D Self-ligating Bracket-M002212R Classic Mini B.ROTH22LR4(W/H) 3D Self-ligating Bracket-M002244R Function SLB-ROTH22 Function SLB-High22 UR2 SD Tube SGL UR7-MBT18 SD Tube SGL UR6-ROTH18 SD Tube SGL Conv.UL6-ROTH22 SD Tube SGL LR7-ROTH18 SD Tube DBL Conv.LR6-ROTH22 SD Tube SGL LR7-MBT22 SD Mini Tube UR7-DQ18 SD Tube SGL LR6-MBT22 SD Tube SGL Conv.LL6-MBT18 SD Tube SGL UR7-ROTH18 SD Tube SGL LL6-MBT18 SD Mini Tube LR7-EDGEWISE22 SD Mini Tube LR7-EDGEWISE18 SD Tube SGL Conv.LL6-ROTH22 SD Tube SGL LL6-ROTH22 SD Tube SGL LL7-MBT18 SD Tube SGL UL7-MBT22 SD Tube DBL Conv.UL6-MBT22 SD Tube SGL UR7-MBT22 SD Tube SGL UL7-ROTH22 SD Tube DBL Conv.LR6-MBT22 SD Tube SGL Conv.UR6-MBT18 SD Tube DBL Conv.UR6-MBT22 SD Tube SGL LL7-ROTH18 SD Tube DBL Conv.UR6-MBT18 SD Tube SGL UR6-ROTH22 SD Tube SGL LL6-ROTH18 SD Tube SGL Conv.UL6-MBT18 SD Tube SGL LL7-ROTH22 SD Tube SGL LR6-ROTH22 SD Tube SGL UL7-MBT18 SD Tube SGL LL7-MBT22 SD Tube SGL LR6-ROTH18 SD Tube SGL UL6-MBT18 SD Mini Tube LL7-EDGEWISE22 SD Tube SGL Conv.UL6-ROTH18 SD Tube SGL UL7-DQ22 SD Tube SGL Conv.UL6-MBT22 SD Tube DBL Conv.LR6-ROTH18 SD Tube DBL Conv.LR6-MBT18 SD Mini Tube UL7-DQ22 SD Tube DBL Conv.UR6-ROTH18 SD Mini Tube LL7-DQ18 SD Tube SGL LR7-ROTH22 SD Tube DBL Conv.LL6-MBT22 SD Tube SGL UL6-MBT22 SD Mini Tube UL7-EDGEWISE22 SD Tube SGL LR6-DQ22 SD Tube SGL LL7-DQ22 SD Tube DBL Conv.UL6-ROTH18 SD Tube SGL UL6-ROTH22 SD Tube DBL Conv.LL6-ROTH22 SD Tube DBL Conv.UL6-MBT18 SD Tube DBL Conv.LL6-MBT18 SD Mini Tube UL7-DQ18 SD Tube SGL UL7-ROTH18 SD Tube SGL UL6-ROTH18 SD Tube SGL LR6-MBT18 SD Mini Tube UR7-EDGEWISE18 SD Tube SGL Conv.LR6-MBT18 SD Tube SGL UR6-DQ22 SD Tube SGL UR6-MBT18 SD Mini Tube LL7-DQ22 SD Tube SGL Conv.UR6-ROTH18 SD Tube SGL Conv.LL6-ROTH18 SD Mini Tube LR7-DQ22 SD Tube DBL Conv.UR6-ROTH22 SD Tube DBL Conv.LL6-ROTH18 SD Tube SGL UR7-ROTH22 SD Tube SGL LR7-MBT18 SD Mini Tube LL7-EDGEWISE18 SD Tube SGL LL6-DQ22 SD Mini Tube LR7-DQ18 SD Mini Tube UR7-EDGEWISE22 SD Tube SGL Conv.UR6-MBT22 SD Tube DBL Conv.UL6-ROTH22 SD Tube SGL Conv.LR6-ROTH18 SD Tube SGL LL6-MBT22 SD Tube SGL UR7-DQ22 SD Mini Tube UR7-DQ22 SD Tube SGL UR6-MBT22 SD Tube SGL UL6-DQ22 SD Tube SGL Conv.LL6-MBT22 SD Tube SGL Conv.LR6-ROTH22 SD Tube SGL Conv.UR6-ROTH22 SD Mini Tube UL7-EDGEWISE18 SD Tube SGL LR7-DQ22 SD Tube SGL Conv.LR6-MBT22 Root Canal Files M1-K Single #15 31mm Root Canal Files M1-VW Single (25/07) 25mm Root Canal Files M1-K Single #8 31mm Root Canal Files M1-VW Single (30/06) 31mm Root Canal Files M1-Pedo Single (25/06) 16mm Root Canal Files M1-C Single #8 21mm Root Canal Files M1-M Single (30/06) 31mm Root Canal Files M1-H Single #40 25mm Root Canal Files M1-P Single S2(20/04) 31mm Root Canal Files M1-H Single #30 25mm Root Canal Files M1-VW Single (45/04) 25mm Root Canal Files M1-Path Single (19/02) 21mm Root Canal Files M1-H Single #35 21mm Root Canal Files M1-C Single #12 19mm Root Canal Files M1-M Single (25/04) 25mm Root Canal Files M1-RT Single (20/07) 22mm Root Canal Files M1-K Single #35 31mm Root Canal Files M1-R Single #55 25mm Root Canal Files M1-Pedo Single (25/04) 16mm Root Canal Files M1-Path Assorted 25mm Root Canal Files M1-K Single #30 31mm Root Canal Files M1-P Single F1(20/07) 25mm Root Canal Files M1-VW Single (35/04) 25mm Root Canal Files M1-R Single #45 21mm Root Canal Files M1-Path Single (13/02) 21mm Root Canal Files M1-R Single #60 21mm Root Canal Files M1-VW Single (45/04) 31mm Root Canal Files M1-R Single #60 31mm Root Canal Files M1-P Single F1(20/07) 31mm Root Canal Files M1-K Single #60 21mm Root Canal Files M1-P Single F2(25/08) 31mm Root Canal Files M1-M Single (30/04) 31mm Root Canal Files M1-R Single #8 21mm Root Canal Files M1-R Single #55 31mm Root Canal Files M1-L Single L5(55/04) 25mm Root Canal Files M1-K Single #10 21mm Root Canal Files M1-R Single #35 25mm Root Canal Files M1-MaxI Single (25/02) 25mm Root Canal Files M1-C Single #12 31mm Root Canal Files M1-T Single T1(10/06) 25mm Root Canal Files M1-P Assorted 31mm Root Canal Files M1-VW Single (35/06) 21mm Root Canal Files M1-R Single #10 21mm Root Canal Files M1-H Single #60 31mm Root Canal Files M1-K Single #10 31mm Root Canal Files M1-K Single #50 25mm Root Canal Files M1-VW Single (50/04) 31mm Root Canal Files M1-R Single #45 31mm Root Canal Files M1-Path Single (13/02) 25mm Root Canal Files M1-P Single S2(20/04) 25mm Root Canal Files M1-K Single #6 25mm Root Canal Files M1-VW Single (60/04) 21mm Root Canal Files M1-R Single #25 21mm Root Canal Files M1-K Single #20 31mm Root Canal Files M1-MaxI Single (25/02) 21mm Root Canal Files M1-K Assorted S 25mm Root Canal Files M1-H Single #55 31mm Root Canal Files M1-M Single (25/06) 31mm Root Canal Files M1-H Single #60 21mm Root Canal Files M1-VW Single (20/06) 25mm Root Canal Files M1-VW Single (40/06) 25mm Root Canal Files M1-M Single (25/06) 25mm Root Canal Files M1-Pedo Single (20/06) 16mm Root Canal Files M1-H Single #55 25mm Root Canal Files M1-K Single #40 31mm Root Canal Files M1-H Single #25 25mm Root Canal Files M1-M Single (30/04) 21mm Root Canal Files M1-Pedo Single (30/04) 16mm Root Canal Files M1-H Single #60 25mm Root Canal Files M1-H Single #20 31mm Root Canal Files M1-H Single #15 31mm Root Canal Files M1-Path Single (16/02) 21mm Root Canal Files M1-K Assorted L 21mm Root Canal Files M1-R Single #10 31mm Root Canal Files M1-P Single S1(18/02) 31mm Root Canal Files M1-TE Single (60/02) 25mm Root Canal Files M1-P Single S1(18/02) 21mm Root Canal Files M1-H Single #35 25mm Root Canal Files M1-R Single #50 21mm Root Canal Files M1-M Single (20/04) 31mm Root Canal Files M1-VW Single (40/06) 21mm Root Canal Files M1-C Single #8 19mm Root Canal Files M1-P Single F3(30/09) 31mm Root Canal Files M1-K Single #6 31mm Root Canal Files M1-VWR Single (15/05) 21mm Root Canal Files M1-K Single #8 21mm Root Canal Files M1-C Single #6 21mm Root Canal Files M1-R Single #40 25mm Root Canal Files M1-M Single (25/04) 31mm Root Canal Files M1-TE Single (50/02) 25mm Root Canal Files M1-T Assorted 25mm Root Canal Files M1-M Single (25/04) 21mm Root Canal Files M1-K Single #55 21mm Root Canal Files M1-L Single L4(45/05) 25mm Root Canal Files M1-K Single #30 25mm Root Canal Files M1-Pedo Single (20/04) 16mm Root Canal Files M1-R Single #35 21mm Root Canal Files M1-C Single #8 25mm Root Canal Files M1-Path Single (16/02) 25mm Root Canal Files M1-MaxII Single (25/02) 25mm Root Canal Files M1-R Single #6 25mm Root Canal Files M1-P Single F3(30/09) 25mm Root Canal Files M1-L Single L7(30/04) 25mm Root Canal Files M1-R Single #40 31mm Root Canal Files M1-P Single F2(25/08) 21mm Root Canal Files M1-L Single L2(25/065) 25mm Root Canal Files M1-H Single #25 21mm Root Canal Files M1-VW Single (35/04) 31mm Root Canal Files M1-R Single #30 25mm Root Canal Files M1-VW Single (10/04) 21mm Root Canal Files M1-K Single #40 21mm Root Canal Files M1-H Single #45 31mm Root Canal Files M1-Pedo Single (30/06) 16mm Root Canal Files M1-VW Single (10/04) 31mm Root Canal Files M1-VW Single (25/06) 25mm Root Canal Files M1-VW Single (20/06) 21mm Root Canal Files M1-C Single #10 31mm Root Canal Files M1-H Single #30 21mm Root Canal Files M1-H Single #20 21mm Root Canal Files M1-K Single #25 25mm Root Canal Files M1-P Single F2(25/08) 25mm Root Canal Files M1-R Assorted L 25mm Root Canal Files M1-R Single #10 25mm Root Canal Files M1-VW Single (30/05) 25mm Root Canal Files M1-H Single #8 21mm Root Canal Files M1-VW Single (35/06) 31mm Root Canal Files M1-L Single L3(35/06) 25mm Root Canal Files M1-R Single #20 31mm Root Canal Files M1-K Single #45 25mm Root Canal Files M1-R Single #60 25mm Root Canal Files M1-H Single #40 31mm Root Canal Files M1-VW Single (40/04) 31mm Root Canal Files M1-R Single #25 31mm Root Canal Files M1-H Single #6 31mm Root Canal Files M1-T Single T3(15/06) 25mm Root Canal Files M1-K Single #25 21mm Root Canal Files M1-RT Assorted ALLmm Root Canal Files M1-RT Single (25/08) 18mm Root Canal Files M1-VW Single (40/04) 25mm Root Canal Files M1-VW Single (25/07) 31mm Root Canal Files M1-VW Single (40/06) 31mm Root Canal Files M1-K Single #55 25mm Root Canal Files M1-VW Single (30/05) 21mm Root Canal Files M1-VW Single (30/05) 31mm Root Canal Files M1-H Assorted S 21mm Root Canal Files M1-R Assorted L 31mm Root Canal Files M1-VW Single (25/07) 21mm Root Canal Files M1-C Single #6 31mm Root Canal Files M1-P Single F3(30/09) 21mm Root Canal Files M1-H Single #8 25mm Root Canal Files M1-R Assorted S 31mm Root Canal Files M1-K Assorted S 21mm Root Canal Files M1-TE Single (40/02) 25mm Root Canal Files M1-T Single T6(30/09) 25mm Root Canal Files M1-R Single #15 31mm Root Canal Files M1-VW Single (15/05) 31mm Root Canal Files M1-VW Single (30/06) 25mm Root Canal Files M1-T Single T4(20/07) 25mm Root Canal Files M1-VW Single (15/05) 21mm Root Canal Files M1-H Single #50 25mm Root Canal Files M1-C Single #10 25mm Root Canal Files M1-H Assorted S 31mm Root Canal Files M1-H Single #45 25mm Root Canal Files M1-R Assorted S 25mm Root Canal Files M1-VW Single (45/04) 21mm Root Canal Files M1-M Assorted 25mm Root Canal Files M1-K Single #50 21mm Root Canal Files M1-L Single L1(20/07) 25mm Root Canal Files M1-H Single #10 21mm Root Canal Files M1-M Single (25/06) 21mm Root Canal Files M1-K Single #35 21mm Root Canal Files M1-K Single #10 25mm Root Canal Files M1-P Assorted 25mm Root Canal Files M1-C Single #6 25mm Root Canal Files M1-H Assorted L 21mm Root Canal Files M1-R Single #45 25mm Root Canal Files M1-R Single #55 21mm Root Canal Files M1-TE Assorted 25mm Root Canal Files M1-VW Single (25/06) 21mm Root Canal Files M1-H Assorted S 25mm Root Canal Files M1-K Single #40 25mm Root Canal Files M1-C Single #12 21mm Root Canal Files M1-P Single F1(20/07) 21mm Root Canal Files M1-T Single T5(25/08) 25mm Root Canal Files M1-K Single #45 21mm Root Canal Files M1-VW Single (25/06) 31mm Root Canal Files M1-H Single #40 21mm Root Canal Files M1-RT Single (30/09) 16mm Root Canal Files M1-TE Single (30/02) 25mm Root Canal Files M1-M Single (30/06) 25mm Root Canal Files M1-M Single (35/04) 21mm Root Canal Files M1-VW Single (50/04) 21mm Root Canal Files M1-C Single #15 21mm Root Canal Files M1-R Single #20 21mm Root Canal Files M1-R Single #35 31mm Root Canal Files M1-R Single #30 31mm Root Canal Files M1-K Single #55 31mm Root Canal Files M1-K Single #8 25mm Root Canal Files M1-H Single #35 31mm Root Canal Files M1-M Single (20/04) 25mm Root Canal Files M1-H Single #15 21mm Root Canal Files M1-H Single #50 31mm Root Canal Files M1-K Assorted L 31mm Root Canal Files M1-R Single #50 25mm Root Canal Files M1-VW Single (50/04) 25mm Root Canal Files M1-H Single #8 31mm Root Canal Files M1-K Assorted S 31mm Root Canal Files M1-VW Single (20/06) 31mm Root Canal Files M1-K Single #15 21mm Root Canal Files M1-K Single #35 25mm Root Canal Files M1-H Single #25 31mm Root Canal Files M1-R Single #40 21mm Root Canal Files M1-K Single #20 21mm Root Canal Files M1-K Single #25 31mm Root Canal Files M1-C Single #15 31mm Root Canal Files M1-VW Single (15/05) 25mm Root Canal Files M1-VW Single (60/04) 25mm Root Canal Files M1-P Assorted 21mm Root Canal Files M1-M Single (19/02) 25mm Root Canal Files M1-K Single #20 25mm Root Canal Files M1-H Single #55 21mm Root Canal Files M1-H Single #6 25mm Root Canal Files M1-VW Single (30/06) 21mm Root Canal Files M1-TE Single (45/02) 25mm Root Canal Files M1-P Single SX(19/04) 19mm Root Canal Files M1-R Single #8 25mm Root Canal Files M1-R Single #25 25mm Root Canal Files M1-M Single (30/04) 25mm Root Canal Files M1-H Assorted L 25mm Root Canal Files M1-R Single #50 31mm Root Canal Files M1-K Single #30 21mm Root Canal Files M1-R Assorted S 21mm Root Canal Files M1-C Single #6 19mm Root Canal Files M1-K Single #50 31mm Root Canal Files M1-K Single #60 31mm Root Canal Files M1-P Single S2(20/04) 21mm Root Canal Files M1-H Single #30 31mm Root Canal Files M1-H Single #10 25mm Root Canal Files M1-M Single (35/04) 31mm Root Canal Files M1-Pedo Assorted 16mm Root Canal Files M1-M Single (17/08) 19mm Root Canal Files M1-M Assorted 21mm Root Canal Files M1-M Single (35/04) 25mm Root Canal Files M1-L Single L6(25/04) 25mm Root Canal Files M1-K Single #6 21mm Root Canal Files M1-VW Single (35/06) 25mm Root Canal Files M1-H Single #15 25mm Root Canal Files M1-M Single (20/04) 21mm Root Canal Files M1-H Single #50 21mm Root Canal Files M1-VW Single (40/04) 21mm Root Canal Files M1-K Assorted L 25mm Root Canal Files M1-R Single #15 21mm Root Canal Files M1-P Single S1(18/02) 25mm Root Canal Files M1-C Single #15 19mm Root Canal Files M1-C Single #12 25mm Root Canal Files M1-R Single #8 31mm Root Canal Files M1-TE Single (35/02) 25mm Root Canal Files M1-K Single #15 25mm Root Canal Files M1-C Single #10 19mm Root Canal Files M1-H Single #45 21mm Root Canal Files M1-M Assorted 31mm Root Canal Files M1-R Single #20 25mm Root Canal Files M1-VW Single (35/04) 21mm Root Canal Files M1-C Single #15 25mm Root Canal Files M1-M Single (19/02) 21mm Root Canal Files M1-R Single #30 21mm Root Canal Files M1-H Single #6 21mm Root Canal Files M1-H Single #10 31mm Root Canal Files M1-MaxII Single (25/02) 21mm Root Canal Files M1-H Assorted L 31mm Root Canal Files M1-M Single (19/02) 31mm Root Canal Files M1-R Single #6 31mm Root Canal Files M1-R Assorted L 21mm Root Canal Files M1-C Single #8 31mm Root Canal Files M1-T Single T2(10/08) 25mm Root Canal Files M1-H Single #20 25mm Root Canal Files M1-VW Single (60/04) 31mm Root Canal Files M1-M Single (30/06) 21mm Root Canal Files M1-K Single #60 25mm Root Canal Files M1-VW Single (10/04) 25mm Root Canal Files M1-K Single #45 31mm Root Canal Files M1-Path Single (19/02) 25mm Root Canal Files M1-Path Assorted 21mm Root Canal Files M1-R Single #15 25mm Root Canal Files M1-C Single #10 21mm Root Canal Files M1-VWR Single (25/05) 21mm Root Canal Files M1-R Single #6 21mm ART-Large-Lower NiTi Open Spring-10*180mm ART-Small-Lower Torquing Spring-19*25M Torquing Spring-18*25 M NiTi closed spring(2.5)13mm150 NiTi Close Spring-12*180mm Torquing Spring-16*22 L ART-Middle-Lower NiTi closed spring(2.5)8mm150g NiTi closed spring(1.5)8mm200g ART-Large-Upper NiTi closed spring(1.5)13mm150 ART-Middle-Upper NiTi closed spring(2.5)13mm250 NiTi closed spring(2.5)8mm200g NiTi Open Spring-12*180mm NiTi Close Spring-10*180mm NiTi closed spring(2.5)13mm200 NiTi closed spring(1.5)8mm150g NiTi closed spring(1.5)13mm250 ART-Small-Upper NiTi closed spring(1.5)13mm200 Torquing Spring-16*22 M Torquing Spring-17*25 L NiTi closed spring(2.5)8mm250g Torquing Spring-18*25 L Torquing Spring-17*25 M NiTi closed spring(1.5)8mm250g Niti Archwire-Upper-20 RCS-Lower-17*25 New Cu-Niti14 Universal Form SS Archwire-Lower-19*25 SS Archwire-Lower-16 Universal-TMA21*25 RCS-Lower-19*25 Universal From-SS-14*25 Thermal-Niti-Upper-18 TMA-Upper-17*25 Stainless Steel Orthodontic Wire-SS111622 NITI Orthodontic Wire-NT001800CU New Cu-Niti20 Universal Form Niti Archwire-Lower-19*25 Niti Archwire-Upper-12 Universal-TMA17*25 Thermal-Niti-Upper-18*18 Niti Archwire-Lower-14 SS Archwire-Lower-12 NITI Orthodontic Wire-NT001400 New Cu-Niti16 Universal Form Niti Archwire-Lower-20 Thermal-Niti-Lower-17x25 SS Archwire-Upper-14 Thermal-Niti-Lower-19x25 Stainless Steel Orthodontic Wire-SS111922 SS Archwire-Upper-12 Universal From-SS-14 Stainless Steel Orthodontic Wire-SS111722 Thermal-Niti-Lower-14 SS Archwire-Lower-17*25 NITI Orthodontic Wire-NT101400 Niti Archwire-Lower-17*25 SS Archwire-Lower-16*16 Thermal-Niti-Upper-16*16 Stainless Steel Orthodontic Wire-SS111616 NITI Orthodontic Wire-NT101800CU Thermal-Niti-Upper-16 Niti Archwire-Upper-14 Thermal-Niti-Upper-12 SS Archwire-Lower-18 Stainless Steel Orthodontic Wire-SS111822 Stainless Steel Orthodontic Wire-SS111825 Universal From-SS-18*25 NITI Orthodontic Wire-NT001200CU Niti Archwire-Upper-18*25 NITI Orthodontic Wire-NT001600 Stainless Steel Orthodontic Wire-SS011722 RCS-Upper-16*16 Thermal-Niti-Lower-18x25 NITI Orthodontic Wire-NT101600CU RCS-Upper-18*25 Niti Archwire-Lower-16*22 TMA-Lower-18*25 Universal From-SS-12 Thermal-Niti-Lower-16*16 Niti Archwire-Lower-16*16 SS Archwire-Upper-19*25 Niti Archwire-Upper-19*25 Seven Strand (twisted) 0175 Niti Archwire-Lower-18*25 NITI Orthodontic Wire-NT001600CU TMA-Lower-17*25 Niti Archwire-Lower-18 SS Archwire-Upper-16 Thermal-Niti-Upper-19*25 Pre-cut Ligature Ties-010 Thermal-Niti-Lower-16 Stainless Steel Orthodontic Wire-SS011925 RCS-Upper-19*25 Universal From-SS-19*25 Thermal-Niti-Upper-14 Niti Archwire-Upper-17*25 Kobayashi Stainless Steel Ligature Ties-012 Niti Archwire-Lower-17*22 Thermal-Niti-Lower-12 SS Archwire-Lower-18*25 Stainless Steel Orthodontic Wire-SS111725 Kobayashi Stainless Steel Ligature Ties-014 NITI Orthodontic Wire-NT001200 New Cu-Niti16x25 Universal Stainless Steel Orthodontic Wire-SS011725 NITI Orthodontic Wire-NT101200 TMA-Upper-16*22 Universal-TMA19*25 Stainless Steel Ligature Ties-012 SS Archwire-Upper-17*25 SS Archwire-Lower-16*22 Universal-TMA14*25 Universal From-SS-18 Stainless Steel Orthodontic Wire-SS111925 Universal-TMA16*25 Thermal-Niti-Upper-16*22 Niti Archwire-Upper-16*16 Thermal-Niti-Lower-16*22 TMA-Lower-16*22 Niti Archwire-Upper-16 Universal-TMA18*25 Niti Archwire-Lower-12 Stainless Steel Orthodontic Wire-SS011922 Universal From-SS-17*25 Stainless Steel Orthodontic Wire-SS011822 Stainless Steel Orthodontic Wire-SS011825 Universal From-SS-16*25 Kobayashi Pre-cut Ligature Ties-012 Thermal-Niti-Lower-18x18 RCS-Lower-16*16 New Cu-Niti21x25 Universal NITI Orthodontic Wire-NT101400CU SS Archwire-Upper-21*25 Niti Archwire-Upper-18 SS Archwire-Upper-16*16 NITI Orthodontic Wire-NT101600 RCS-Lower-16*22 Thermal-Niti-Upper-17*25 Niti Archwire-Lower-16 New Cu-Niti18x25 Universal SS Archwire-Upper-18*25 Niti Archwire-Upper-16*22 NITI Orthodontic Wire-NT101800 Stainless Steel Orthodontic Wire-SS011616 Universal From-SS-16*16 Stainless Steel Orthodontic Wire-SS011622 New Cu-Niti14x25 Universal SS Archwire-Lower-21*25 NITI Orthodontic Wire-NT001800 Thermal-Niti-Upper-18*25 RCS-Upper-16 Seven Strand (twisted) 0155 RCS-Upper-18 RCS-Lower-18 RCS-Lower-18*25 Thermal-Niti-Lower-18 RCS-Upper-16*22 NITI Orthodontic Wire-NT101200CU New Cu-Niti18 Universal Form Niti Archwire-Upper-17*22 Universal From-SS-16 SS Archwire-Upper-16*22 SS Archwire-Lower-14 TMA-Upper-18*25 Stainless Steel Ligature Ties-010 SS Archwire-Upper-18 New Cu-Niti13 Universal Form New Cu-Niti19x25Universal NITI Orthodontic Wire-NT001400CU RCS-Upper-17*25 RCS-Lower-16 PS ANGLE BLADE S IS ANGLE BLADE L MS ANGLE BLADE S IS BLADE L MS BLADE L AS BLADE S PS BLADE S AL HANDLE L AL HANDLE S AS ALGLE BLADE L FT ANGLE BLADE S PS BLADE L FT ANGLE BLADE L MS BLADE S PS ANGLE BLADE L FT BLADE L IS BLADE S MS ANGLE BLADE L AS BLADE L FT BLADE S AS ANGLE BLADE S IS ANGLE BLADE S

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EJF Bracket, Metal, Orthodontic Dental Class 1 872.5410 2019-12-30
DZD Tube, Orthodontic Dental Class 1 872.5410 2019-12-30
EKS File, Pulp Canal, Endodontic Dental Class 1 872.4565 2025-02-12
ECO Spring, Orthodontic Dental Class 1 872.5410 2025-02-12
DZC Wire, Orthodontic Dental Class 1 872.5410 2019-12-30
DZN Instruments, Dental Hand Dental Class 1 872.4565 2025-02-12

Official Correspondent

Anita Chen

US Agent Details

ChiuYen Chen Email: m9104303@gmail.com Phone: (619) 7636595

Related Public Records

Same Entity

ZE FANG TECHNOLOGY CO., LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K894358 Ormco Corp. LUMINA ORTHODONTIC BRACKET 1989-09-15
K925012 American Orthodontics PLASTIC CHAIN 1993-09-13
K864976 Endo Technic Corp. SOLUSET CALCIUM DEMINERALIZING SOLUTION 1987-02-27
K112640 Ormco Corp. HYPERELASTIC WIRE 2011-11-16

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Registration Number Establishment Name Location
3010462491 DW Lingual Systems GmbH Bad Essen Lower Saxony, DE
3009257060 Ortho Traction Pads Norwalk, CT, US
3027343382 UNIVY TECHNOLOGY ADVANCED CO. LTD Shanghai, CN
3023443842 HENAN BAISTRA MEDICAL DEVICES LIMITED Zhengzhou Henan, CN
3012232878 SUNSTAR TRADING INTERNATIONAL LIMITED Kowloon Hong Kong, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013689189. Last updated year: 2026. Please use registration number 3013689189 when referencing this establishment in official correspondence.
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