Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006034256

FEI Number

3006034256

Entity Name

DENTOS, INCORPORATED

City/State/Country

DAEGU, KR

Establishment Address

41, Seongseo-ro 68-gil, Dalseo-gu, DAEGU 42697, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DENTOS, INCORPORATED (Owner Number: 9081942)

Owner / Operator Contact Address

41, Seongseo-ro 68-gil, Dalseo-gu, Daegu, KR-NOTA 42697, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CF (Cotton Forcep) EF-L (Extracting Forcep-L) EF-U (Extracting Forcep-U) MCF (Mini Cotton Forcep) VCH-L-2 VCH-L-3 VCH-CS VCH-R-4 VCH-R-2 VCH-R-1 VCH-L-1 CH-L VCH-R-3 CH-S VCH-L-4 AMPLC (Angled Mini-Pin Ligature Cutter) YP (Young Plier) TRP (Tweed Rectangular arch wire bending Plier) BP (Broussard Plier) OLFP (Omega Loop Forming Plier) LUP (Lingual Utility Plier) CSH (Coil Spring Holder) LWC (Ligature Wire Cutter) Turret-S SDEC (Safety holder type of flush Distal End Cutter) TH (Tube Holder) CHP (Crimpable Hook Plier) LT (Ligature wire Tucker) NTDP (NiTi Distal wire bending Plier) BH (Bracket Holder) OH (O-ring Holder) BR (Band Remover) DEC (Distal End Cutter) UP (Utility Plier) 3PP (3 Prong plier) LWH (Ligature Wire Holder) HP (Hollow chop plier) KP (Kim's Plier) SPLC (Standard mini-Pin Ligature Cutter) HBBP (Heavy Bird Beak Plier) BBP (Bird Beak Plier) APLC (Angled Pin & Ligature Cutter) LBR (Lingual Bracket Remover) CCR (Convertible Cap Remover) Turret-L AT (Arch wire Tucker) 3PPM (Mini 3 Prong plier) HPAP(Hole Punch Aligner Plier) TDAP(Tear Drop Aligner Plier) HAP(Horizontal Aligner Plier) RAP(Retention Aligner Plier) VAP(Vertical Aligner Plier) NTDP-S(NiTi Distal wire bending Plier-S) NTDP-T(NiTi Distal wire bending Plier-T) CBRP(Ceramic Bracket Removing Plier) NT-OS NT20-13H NT20-13L NT15-13H NT20-13M NT20-8U NT15-13U NT25-13U NT20-13U NT15-13M NT15-8M NT15-13L NT15-8L NT25-8U NT25-8H NT25-13L NT15-8H NT25-13M NT20-8M NT25-13H NT15-8U NT25-8M NT20-8L NT25-8L NT20-8H ABSO ANCHOR MICROIMPLANT SF-P SF-C SF-Y SF-B SF-W SF-SET PD-25-1 PD-24-1 PD-24-1.1 PD-25-1.2 PD-31-1.1 PD-24-0.9 PD-31-1.2 PD-31-0.9 PD-24-1.2 PD-25-0.9 PD-25-1.1 PD-31-1 N-18X18-L4 NR-14X25-TL NP-19X25-TL LAB-45-12 S-20X25-L3 NTS-16X25 S-20X25-U6 NP-17X17-TU S-10-L2 ND-20X25-TL N-08-U6 NS-21X25-TL NS-16X16-OU N-14X25-L1 N-14X25-L2 S-20-U6 S-20X25-U5 NS-18-OL S-16 X 22-U6 NL-18X18-U4 NP-18-EU NP-20-TU ND-18X25-TU NP-14-EU NA-RE-L7 SR-20-EU NS-215X28-OL NA-RO-U1 S-16-L1 S-16-L2 LAB-60-500 S-16 X 25-L2 N-21X25-L2 NP-18-TL N-18X25-L2 NR-17X25-TU N-21X25-L4 NA-RS-U2 N-18X18-U5 S-17 X 17-L1 S-18X22-U5 SR-16X25-TU S-215X28-U4 S-17X22-L4 N-16X25-U6 S-14-U4 N-20-L4 NS-20-OU NB-RO-U1 ND-18X22-TU N-18-L3 LAB-60-12 N-16-L2 NP-14-TL NS-08-TL NS-18-OU N-16X25-L1 SR-21X25-EU N-14X25-L4 NP-18-TU ND-20X25-TU NB-RE-L3 NS-20X25-OU S-21X25-L2 NA-RS-L4 N-16 X 16-L3 S-10-L4 N-17 X 17-L4 ND-16X22-TU NP-08-TU N-16 X 22-U5 SR-18X25-EL NB-RE-L10 N-14X25-U5 S-215X28-L3 SR-17X25-EL NS-17X25-TU N-16X25-U4 NB-RO-U5 NP-18X18-TL LAB-50-12 S-17X25-U6 S-16 X 16-U5 S-20-L4 SL-12-TW NR-18X25-TU SR-17X22-TL NA-RO-U2 N-20-L3 ND-19X25-TU NS-16X22-TL S-20-U4 N-14-U6 SS-19X25 NP-18X22-TL S-16-U6 NTS-10 NP-10-EU NA-RE-U3 N-12-U4 SR-14X25-TU S-12-L4 NR-215X28-TU S-18-U6 NS-18X25-OL NR-14-TU S-16 X 25-U6 N-16-L3 NA-RE-U8 SR-21X25-EL NS-20-OL N-16X25-U5 NS-14-OL NR-19X25-TL SS-16X25 NA-RE-U1 NS-10-TU S-19X25-U4 S-16 X 25-U4 NTS-08 N-16 X 22-L3 SR-17X22-EU NL-18X18-L4 S-17 X 17-L3 S-17X22-L3 NA-RO-U7 N-17 X 17-U5 SR-14-TL NS-19X25-OL NR-10-TU NR-12-TL N-14-L3 LAB-120-12 N-12-U6 NR-17X22-TU NA-RE-U6 SR-16-EU NS-17X17-TU SR-18X25-EU NS-08-TU N-17X25-U5 S-18X18-L1 NS-20X25-TU SR-12-EU N-18-U5 SR-14X25-EL NA-RE-L9 N-10-U6 NS-21X25-OU S-215X28-L1 S-18X18-L4 NS-17X22-OL NB-RE-U9 N-10-U4 N-17X25-L3 SR-17X22-EL S-19X25-L2 S-16 X 16-L4 NB-RE-U3 NA-RE-L10 S-19X25-L4 S-21X25-L4 NS-215X28-OU NS-16X22-OU NB-RO-L1 S-14-L1 NA-RS-L1 NB-RO-L7 N-19X25-L3 N-16 X16-U4 SR-18X22-EL N-16-U6 ND-18X18-TL NP-21X25-EU N-18-U4 SR-17X25-EU SR-14-EU S-18X25-L4 NS-08-OL N-14-L1 NTS-14 NP-17X25-TU S-215X28-L2 NS-215X28-TU NS-16X25-TL N-12-U5 S-16-U4 SR-17X22-TU NR-14-TL N-14-U4 NP-21X25-TU N-14-L4 S-18X25-L2 S-20X25-L4 NB-RO-L5 N-18X18-U6 NS-18X25-TU SS-17X22 NA-RE-L2 S-14-U6 S-18X18-L2 NA-RE-L5 SL-12-SP N-17X25-L4 S-17X22-L1 N-12-L1 ND-16X16-TL NB-RE-U4 S-10-U5 NP-12-EU NR-16-TU S-18X22-U4 NR-21X25-TU ND-18X18-TU NR-215X28-TL NR-20X25-TU NS-19X25-TU SR-19X25-TU NS-17X22-TU S-17X25-U4 N-14-U5 S-20-L1 NR-21X25-TL ND-10-TL S-14-U5 NS-14X25-TL SR-20-TU N-16 X 16-U5 SR-215X28-EL NP-20X25-TL N-17X25-U4 SR-215X28-TL N-12-L4 N-19X25-U4 LAB-80-12 SR-215X28-EU NS-20-TL NB-RO-L3 N-18X25-U4 SL-08-TW ND-21X25-TL NA-RO-U6 NP-215X28-TL NS-18X25-TL LAB-40-12 S-20-L3 NS-14X25-TU NS-16X16-TU SR-17X17-EL NTS-17X25 SR-18-TL S-17 X 17-U6 S-12-L3 NS-12-OU NTS-20 N-08-L4 NR-18-TU NR-18X18-TL NP-16X16-TL SR-16X22-EL ND-08-TU NP-14X25-EU NS-21X25-TU NR-08-TL NB-RO-L6 NP-16X25-TL S-16-L3 N-20-L1 SR-14-TU NS-16X25-OL NP-08-EU SR-16X25-TL NP-16-TU SS-18 S-19X25-L3 N-21X25-U4 S-18X22-L3 SS-20X25 ND-215X28-TL S-18-L2 S-18-U5 NB-RE-U5 S-19X25-U6 N-16-U4 SR-215X28-TU SR-19X25-TL S-20-U5 S-21X25-L3 NA-RO-U5 SR-16-TU S-18X18-U4 SR-21X25-TL NR-16X25-TU SR-10-TU N-17X25-L2 S-215X28-L4 N-18X25-L1 S-16-U5 N-18-U6 LAB-100-12 NB-RS-L1 NP-18X18-TU ND-17X25-TU NL-17X17-L4 S-12-L2 S-215X28-U6 S-16 X 22-L3 SR-12-TL NP-215X28-TU N-19X25-L1 N-18X25-U5 N-18X25-U6 N-16 X 22-L2 ND-14X25-TL LAB-90-12 NTS-16X16 N-10-L4 S-18-L1 N-20-L2 S-18X22-L4 N-10-L2 N-17 X 17-L3 ND-14-TL SR-20X25-TU S-17 X 17-L2 S-17X25-L1 S-18X18-U5 NS-17X17-OU N-17X25-L1 ND-18-TU SR-19X25-EU S-19X25-U5 NP-19X25-TU NB-RE-U2 NA-RO-L4 SS-14X25 NB-RE-L2 NB-RE-L6 N-16 X 16-L1 NS-18X18-OU ND-215X28-TU NP-16X22-EU S-12-L1 NA-RS-L3 NS-16X22-TU S-18X25-L1 S-17X25-L3 N-10-L1 ND-17X22-TU NS-18-TL S-20X25-L1 NS-17X22-TL NB-RO-U4 S-16 X 25-L4 N-16 X 22-U4 NA-RE-U9 N-14X25-L3 ND-17X22-TL N-16 X 16-L4 ND-18X22-TL LAB-35-500 NP-16X16-TU S-18X25-L3 N-18X18-L2 ND-17X17-TL N-08-L2 NP-10-TL NS-08-OU NR-16X16-TU NB-RO-U2 NP-16X22-TL S-17X25-U5 S-16 X 16-U4 NTS-16 NS-18X18-TU S-16 X 16-L2 NR-08-TU NS-14-OU NP-17X17-TL NA-RE-U2 SS-17X17 S-16 X 22-U4 S-215X28-U5 NS-19X25-TL NS-17X25-TL N-19X25-U6 NR-18X22-TU NA-RE-L1 NA-RE-L6 NS-18X22-TL N-21X25-U6 SR-20X25-EL NB-RS-U4 NB-RS-U3 LAB-45-500 N-10-U5 NR-17X17-TU NS-17X17-TL NP-17X22-TU NR-16X22-TU NR-18X22-TL S-12-U6 SR-16X16-TU NP-18X25-TU SR-20X25-TL NS-17X17-OL ND-21X25-TU NB-RO-U6 S-18X22-U6 SS-12 NP-20X25-EU NS-12-OL S-14-L2 NS-10-OU N-16-L4 LAB-70-12 NP-12-TL NB-RE-U6 SR-18X22-TL NS-16-TU S-12-U5 S-16 X 22-L4 NA-RS-U3 N-08-L1 N-18-L4 SR-17X17-EU NS-18X22-OU S-14-L3 LAB-50-500 NP-17X17-EU SR-18X22-TU NA-RO-L2 S-18X25-U6 LAB-120-500 S-16 X 22-L2 S-16 X 25-U5 NS-16X16-OL S-10-U4 NP-08-TL SS-18X25 SS-21X25 S-18X22-L1 N-20-U5 ND-12-TU SR-19X25-EL NB-RE-L5 S-18X25-U5 NR-16-TL N-18-L2 S-10-L3 NR-17X22-TL NR-19X25-TU SS-18X22 NS-17X25-OL N-17 X 17-U6 N-21X25-L3 N-16 X 22-U6 N-12-L3 SR-12-TU NB-RS-L4 NS-20-TU S-18-L4 SR-10-EL N-10-L3 S-21X25-U6 S-17 X 17-U5 NA-RO-L5 NP-16X25-TU NS-16-TL N-16 X 16-U6 NA-RO-L1 N-12-L2 NR-10-TL ND-12-TL SR-18X22-EU N-16X25-L2 N-19X25-U5 N-20-U4 ND-16-TL ND-17X17-TU NR-14X25-TU NS-16X25-TU SS-20 N-08-L3 NR-16X22-TL NA-RS-U1 NA-RS-L2 S-21X25-L1 SR-16X16-TL N-16-L1 NP-18X22-TU NP-18X22-EU SR-12-EL NB-RE-U7 NA-RE-U7 ND-20-TU SS-16 SL-10-TW N-20-U6 NB-RE-L4 NTS-17X17 NP-215X28-EU SS-17X25 N-16-U5 N-08-U4 ND-16X22-TL N-08-U5 NB-RO-U3 S-16-L4 NB-RO-L2 NP-18X18-EU NA-RE-U5 NS-18X22-TU NA-RE-U4 NB-RE-L9 ND-08-TL NP-18X25-EU NB-RE-L8 NB-RE-U1 LAB-90-500 NS-18-TU N-17 X17-U4 NR-20X25-TL NTS-14X25 NS-18X18-OL SS-215X28 SR-14-EL SR-20X25-EU NP-17X25-TL ND-18X25-TL SR-18-TU SR-16X22-TL NB-RS-U1 NP-10-TU S-16 X 16-L1 NR-18-TL NA-RO-L6 SR-18-EU NA-RE-L4 LAB-80-500 NP-16-TL SR-17X17-TL NR-16X16-TL SL-09-TW NP-12-TU NA-RE-U10 SL-08-SP SR-16-TL S-16 X 22-L1 SR-21X25-TU NS-18X25-OU S-16 X 16-U6 NS-20X25-TL N-18X18-U4 N-14X25-U6 NS-19X25-OU N-17 X 17-L1 S-21X25-U4 S-21X25-U5 NS-14-TL S-18X22-L2 S-17X22-U4 ND-19X25-TL SR-16X25-EL S-17 X 17-L4 NA-RE-L8 NS-16X22-OL N-16 X 22-L4 NS-18X22-OL SS-10 S-16 X 25-L1 NTS-16X22 NP-17X22-EU LAB-100-500 NB-RE-L7 NA-RO-U3 SR-20-TL SS-16X22 S-14-L4 S-10-U6 ND-10-TU SS-16X16 NR-17X25-TL SR-16-EL S-18X25-U4 NP-20X25-TU S-16 X 22-U5 S-20X25-U4 N-16X25-L4 S-17X22-U5 NP-16X22-TU NS-16X25-OU NS-17X22-OU NP-14X25-TL NA-RO-L3 SR-16X16-EL S-19X25-L1 N-19X25-L4 ND-20-TL LAB-35-12 NS-12-TL NB-RO-U7 NP-20-TL NL-17X17-U4 NS-16X16-TL NTS-18X25 S-18-L3 N-16 X 16-L2 NP-16X16-EU NA-RO-U4 NB-RE-U8 ND-14-TU N-21X25-L1 NS-16-OL S-17X22-L2 NS-20X25-OL NA-RS-U4 N-14X25-U4 SR-10-TL N-16X25-L3 N-18X25-L3 N-16 X 22-L1 SR-18X25-TL NS-18X18-TL NS-10-TL NR-18X18-TU ND-16X16-TU N-19X25-L2 NB-RS-L3 NA-RE-L3 S-16 X 25-L3 S-17X25-L2 NP-19X25-EU SR-14X25-TL NB-RS-L2 NA-RO-L7 NP-14-TU N-18-L1 NTS-18X18 LAB-40-500 ND-18-TL SR-10-EU SR-17X17-TU N-18X18-L3 NB-RE-U10 NP-21X25-TL NP-16-EU ND-16-TU NS-14-TU NP-17X22-TL SR-17X25-TU NS-14X25-OL NP-17X25-EU S-18X18-L3 NP-14X25-TU SR-16X22-TU NTS-12 S-20X25-L2 NTS-21X25 N-17X25-U6 N-18X18-L1 N-18X25-L4 SR-18X25-TU N-21X25-U5 S-10-L1 ND-16X25-TL S-18X18-U6 NR-18X25-TL NS-17X25-OU SR-20-EL NR-20-TL SR-18-EL NS-12-TU SR-16X22-EU NS-14X25-OU NR-12-TU S-20-L2 N-14-L2 S-17X25-L4 ND-17X25-TL NP-20-EU SS-14 NR-16X25-TL NTS-19X25 NS-16-OU SL-10-SP NS-215X28-TL NP-16X25-EU SL-09-SP ND-16X25-TU S-16 X 16-L3 S-17 X 17-U4 S-18-U4 N-17 X 17-L2 NB-RS-U2 S-12-U4 NR-20-TU NTS-18 SR-16X25-EU SR-16X16-EU NB-RO-L4 S-17X22-U6 NS-10-OL ND-14X25-TU NB-RE-L1 SR-14X25-EU SR-17X25-TL NP-18X25-TL NR-17X17-TL NS-21X25-OL LAB-70-500 ST-055 W5-G M4-G W5-C M4-C W4-C M5-G W4-G N5-G M5-C N4-C N4-G ST-045 N5-C

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2010-07-02
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2010-07-02
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2010-07-02
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2010-07-02
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2006-08-24
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2015-03-12
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2010-07-02
OAT	Implant, Endosseous, Orthodontic	Dental	Class 2	872.3640	2019-02-18
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2010-07-02
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2010-07-02

Official Correspondent

No official correspondent registered.

US Agent Details

Mateo Carrasco Business: Carrasco Email: info@afpharmaservice.com Phone: (407) 2849480

Related Public Records

Same Entity

DENTOS, INCORPORATED

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
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14
K903999	O Co., Inc.	OBUTMENT HB	1992-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Z-0029-05	Implant Innovations, Inc.	2	EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006034256. Last updated year: 2026. Please use registration number 3006034256 when referencing this establishment in official correspondence.