Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005831677

FEI Number

3005831677

Entity Name

B&L BIOTECH CO., INC

City/State/Country

Ansan City Gyeonggi, KR

Establishment Address

#421,#420, 453, Byeolmang-ro, Danwon-gu, Ansan City Gyeonggi 15599, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

B&L BIOTECH CO., LTD. (Owner Number: 9082994)

Owner / Operator Contact Address

#421,#420, 453, Byeolmang-ro,, Danwon-gu, Ansan-si, KR-41 15599, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BLPOT-BPFS5 BLPOT-BPFS3 BLPOT-BPFG BLPOT-BPFB BLPOT-BPFP B&L GP Gauge & Cutter- GGAC B&L Gutta percha JIHG JETip Instrument JIHY JIHB JIHS JXHS JXHG JXHB JXHY WL-B1 B&L-Beta AP-A1 Alpha Plus BP-B1 Beta Mini CL-A1 B&L-Alpha II Obtura Spartan 55/8 taper Plugger Obtura Spartan 55/.10 taper Plugger Obtura MaxPack System Alpha II Plugger BP4504 Obtura Spartan 40/4 taper Plugger Obtura Spartan 45/4 taper Plugger Alpha II Plugger BP4004 Alpha II Plugger BP5510 Alpha II Plugger BP5506 Obtura Spartan 60/.12 taper Plugger Obtura Spartan 35/4 taper Plugger Obtura Spartan 55/6 taper Plugger Alpha II Plugger BP5004 Alpha II Plugger BP5508L Alpha II Plugger BP3504 Alpha II Plugger BP6012 Alpha Alpha II CL-A1 Alpha Enclosure Alpha II Plugger BP5508 Thermal Protector Caps Silicone Cover BPAN AC adaptor protector cap WL-B1 B&L Beta Alpha II HT5508L 55/08 taper plugger long type HT4004 40/04 taper Plugger HT5004 50/04 taper Plugger Hottip CL-A1 HT6012 60/12 taper pluger HT5508 55/08 taper plugger Micro plugger JP6JP7 Ball Burnisher & Micro plugger JB2JP3 HT5506 55/06 taper plugger Hottip Alpha II CL-A1 HT4504 45/04 taper Plugger HT3504 35/04 taper Plugger Hotshot BP-B1 Beta Mini Hotshot BP-B1 HT3004 30/04 taper Plugger HT5510 55/10 taper plugger JETip Instrument Well-Paste VP-A BL Tip JETip BL-3-A STS-5A BL-5-A BL-1-A Hot Testing Tip HTT JT-2L-A JTEFA JT-2S-A JT-2R-A CK tip JT-2B-A BLSKA S tip IS Tip Vibra Post Tip CSA DS-SA DS-LE DS-XE DS-LA CSE DB-0E DS-RA DS-XLA PVSE DS-XRE DB-0A DS-XRA TS-LE PVSC TS-LA DS-RE PVSBA PVSBE TS-SA TS-RA Z.Post PVSA DS-XLE DS-SE DB-3E DS-XA TS-RE TS-SE DB-3A B&L Mirror JETip Instrument JIMM2 B&L Jetip Instrument Micro Mirror DMP4 DMHG PEM JX5H DMF4 Jet X Currette JETip Instrument JC13JC14 JX1JX2 B&L Jetip Leetrac LTNBR LTSBR KTN2S LTRML KimTrac KTNNH LTRMS KTN4N KTN2N KTN1S LTNML KTNSS LTNMS KTN3N KTN1N KTN3S KTN4S KTNNS Obtura Spartan Hot Pulp Testing Tip Jet X Change B&L Jetip B&L MTA Pallet B&L Jetip Instrument Catroviejo Microsurgical Instrument Tip JM1JM2 JISSE (B&L Jetip Instrument Essential Set) TJISSE (B&L Titanium Jetip Instrument Essential Set) TJISSB (B&L Titanium Jetip Instrument Surgical Basic Set) JISSB (B&L Jetip Instrument Surgical Basic Set) JISSS (B&L Jetip Instrument Surgical Suture Set) B&L Paper Point BL-S Kondenser 50/100-L BP5506 BP5510 Beta Mini Starter Kit (Pink) ESKP BL-Condenser (various model #s) BKX35 BL-B Kondenser (35/70) BL-S Kondenser 40/80 BP5508 BL-S Kondenser 60/120-L BL-S Kondenser 35/70-L BP4504 BL-S Kondenser 50/100 BP5508L B&L Beta Starter Kit (Black) BSKB BKX40LT BL-B Kondenser Long (40) BKX60L BL-B Kondenser Long (60/120) BL-S Kondenser SET BKX35LT BL-B Kondenser Long (35) BKX50 BL-B Kondenser (50/100) BKXSETL BL-B Kondenser Long Set (35/70, 40/80, 50/100, 60/120) BKX50LT BL-B Kondenser Long (50) BKX80T BL-B Kondenser (80) BKXSET BL-B Kondenser Set(35/70, 40/80, 50/100, 60/120) BKX35T BL-B Kondenser (35) B&L Alpha II Starter Kit (Pink) ASKP BL-S Kondenser 40/80-L Beta Mini Starter Kit (White) ESKW BL-S Kondenser L SET B&L Alpha II Starter Kit (Black) ASKB B&L Beta Starter Kit (White) BSKW BL-S Kondenser 35/70 BKX60LT BL-B Kondenser Long (60) B&L Beta Starter Kit (Pink) BSKP SPRDS BKX40L BL-B Kondenser Long (40/80) BKX60T BL-B Kondenser (60) BKX50L BL-B Kondenser Long (50/100) BP5004 BP3504 HTT Beta Mini Starter Kit (Black) ESKB BP3004 BKX50T BL-B Kondenser (50) BP6012 BKX70T BL-B Kondenser (70) BP4004 BKX12T BL-B Kondenser (120) SPRDN BL-S Kondenser 60/120 B&L Alpha II Starter Kit (White) ASKW BKX35L BL-B Kondenser Long (35/70) BKX60 BL-B Kondenser (60/120) BKX40 BL-B Kondenser (40/80) BKX40T BL-B Kondenser (40) BKX10T BL-B Kondenser (100) HHTT Hot Testing Tip B&L Jetip Z.Post WARMO PW-A1 WARMA PW-A2 JETip Surgical Curete Offset (Left) JXSCL JetXchange Curette JXCYY Large Gracey Curette JXLG2 Horse Currette (Left) JXHCL JetXchange Curette half (1 tip) JXCC4LY Molt Curette Offset (Left) JXMCL Curette Scaler (Left) JXCSL JetXchange Curette half (1 tip) JXCC4RY JETip Instrument Surgical Curette Straight JXSC2 JetXchange Curette JXCBB Curette Scaler (Right) JXCSR Mini Gracey Curette JXMG2 Large Gracey Curette JXLG1 Molt Curette Offset (Right) JXMCR Horse Currette (Right) JXHCR JetXchange Curette JXCNN Surgical Curete Offset (Right) JXSCR Surgical Curette Straight JXSC1 JetXchange Curette half (1 tip) JXCG14B JetXchange Curette half (1 tip) JXCG12N JetXchange Curette half (1 tip) JXCG11N JetXchange Curette JXCGG JetXchange Curette half (1 tip) JXCDH5G JetXchange Curette half (1 tip) JXCJ33G JetXchange Curette half (1 tip) JXCG13B Mini Gracey Curette JXMG1 Surgical Curette Straight JC9JC10 Mini Gracy Curette JC3JC4 Molt Curette Offset (Left & Right) JC15JC16 Mini Gracy Curette JC1JC2 Surgical Curette Offset (Left & Right) JC15JC16 COMO POMO NGR#1 NGR#2 PT-1A PT-2E PT-3A PT-1E PT-2A PT-3E Leetrac Blade protrude 1 LTNBP Leetrac Blade rectangle LTRBS Leetrac Blade round LTNBR Leetrac Blade small rectangle LTNBT Leetrac (Wide handle) LTRNS Leetrac Blade rectangle small LTSBS Leetrac handle LRTNH Leetrac Blade rectangle LTNBS Leetrac handle LRNNH Leetrac Blade round LTRBR Leetrac Blade trapezium LTRBT Leetrac (Narrow handle) LTNNS Leetrac Blade protrude 2 LTNBQ INF25 INF30 DGR Digital Ruler INF35 ENRML: Endo Ring Large ENBRGL (Endo Bracelet Gray Large) ERSET5 MRSET4 MRSET18 INF20 ENBRGS (Endo Bracelet Gray Small) ENBSSL EMSET3 ENBRBL (Endo Bracelet Black Large) MRSET1 EMSET6 ERSET10 MRSET23 MRSET8 MRSET22 ENMSLG-L ENBRBS (Endo Bracelet Black Small) ERSET12 ENMRDS ENMRDL ERMBR: Endo Ring Main Body Right ENBSSR ERMGN: Endo Ring Magnetic MRSET10 ENBRBL ENMMGD ENBSLL ENMMBR2 ENRMS: Endo Ring Small ENMSLB-R ENBRL ERSET1 MRSET14 ENMSSG-R ENMSSB-L ENMSSB-R EMSET5 ERSET9 ENMRDM ERSET6 MRSET5 MRSET19 ENBMB ENMMGB MRSET13 ERSET4 MRSET3 MRSET17 ERSET7 MRSET6 MRSET20 EMSET7 ERSET11 MRSET24 MRSET7 MRSET21 MRSET11 ERSET3 MRSET16 ERSET2 MRSET15 ENBSP ENMMB6-L Endo M Main Body DLC Left (6EA) EMSET4 ERSET8 ENMMB1-L Endo M Main Body DLC Left (1EA) ENMMB3-R Endo M Main Body DLC Right (3EA) ENBRBS EMSET8 ENBSLR ERMBL: Endo Ring Main Body Left ENBRLR MRSET12 ENBRLL EMSET1 MRSET2 ENMSSG-L EMSET2 Product Name ENMMB2-L Endo M Main Body DLC Left (2EA) ENMSLB-L MRSET9 ENMSLG-R ENMMB6-R Endo M Main Body DLC Right (6EA) ENMMB1-R Endo M Main Body DLC Right (1EA) ENMMBRB ENMMB3-L Endo M Main Body DLC Left (3EA) ENMMB2-R Endo M Main Body DLC Right (2EA) ENMMB10-L Endo M Main Body DLC Left (10EA) ENMMB10-R Endo M Main Body DLC Right (10EA) CIF90 CI120-E CIF120 CI90-A CI90-E CI120-A

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKA	File, Margin Finishing, Operative	Dental	Class 1	872.4565	2019-12-10
EKM	Gutta-Percha	Dental	Class 1	872.3850	2012-12-11
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2010-04-06
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2006-06-20
EKC	Excavator, Dental, Operative	Dental	Class 1	872.4565	2010-04-06
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2010-07-29
JET	Pick, Massaging	Dental	Class 1	872.6650	2009-03-02
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2010-04-06
EKT	Curette, Endodontic	Dental	Class 1	872.4565	2010-04-06
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	2011-09-08
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2011-04-01
EAT	Tester, Pulp	Dental	Class 2	872.1720	2018-03-09
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2011-09-08
EKQ	Preparer, Root Canal Endodontic	Dental	Class 1	872.4565	2012-12-17
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2010-01-04
EJY	Pliers, Operative	Dental	Class 1	872.4565	2011-09-08
ELR	Post, Root Canal	Dental	Class 1	872.3810	2009-03-02
QGO	Composite Resin Warmer	Dental	Class 1	872.6100	2025-03-18
JEW	Tip, Rubber, Oral Hygiene	Dental	Class 1	872.6650	2010-04-06
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	2010-04-06
KXR	Applicator, Resin	Dental	Class 1	872.3140	2016-02-17
EJL	Bur, Dental	Dental	Class 1	872.3240	2024-08-26
EMO	Knife, Periodontic	Dental	Class 1	872.4565	2018-05-02
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2011-07-13

Official Correspondent

No official correspondent registered.

US Agent Details

Daniel Kamm Business: Kamm & Associates Email: fda.help.now@gmail.com Phone: (847) 3741727

Related Public Records

Same Entity

B&L BIOTECH 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
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14
K821275	Conphar, Inc.	MAYO SCISSOR STRAIGHT 5 1/2	1982-05-28
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005831677. Last updated year: 2026. Please use registration number 3005831677 when referencing this establishment in official correspondence.