Data / Medical devices / South Korea / B&L Biotech Co., Inc

B&L Biotech Co., Inc: FDA-registered device maker in Ansan City Gyeonggi, South Korea, 2 510(k) clearances

Name: B&L Biotech Co., Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

B&L Biotech Co., Inc is registered with the FDA (registration 3005831677) in Ansan City Gyeonggi, South Korea. It lists 32 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 21, 2009. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3005831677
Address: #420, 421, Byeolmang-ro Danwon-gu, Ansan City Gyeonggi, South Korea, 15599
Owner or operator: B&L BIOTECH CO., LTD. (9082994)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: June 20, 2006
Registered through: 2027
Brand names listed: AC adaptor protector cap, AP-A1 Alpha Plus, Alpha, Alpha Enclosure, Alpha II, Alpha II CL-A1, Alpha II Plugger BP3504, Alpha II Plugger BP4004 and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Applicator, Resin	KXR	1	Manufacturer	accessdata.fda.gov
Bur, Dental	EJL	1	Manufacturer	accessdata.fda.gov
Carrier, Amalgam, Operative	EKI	1	Manufacturer	accessdata.fda.gov
Composite Resin Warmer	QGO	1	Manufacturer	accessdata.fda.gov
Curette, Endodontic	EKT	1	Manufacturer	accessdata.fda.gov
Curette, Surgical, Dental	EMK	1	Manufacturer	accessdata.fda.gov
Dam, Rubber	EIE	1	Manufacturer	accessdata.fda.gov
Elevator, Surgical, Dental	EMJ	1	Manufacturer	accessdata.fda.gov
Excavator, Dental, Operative	EKC	1	Manufacturer	accessdata.fda.gov
Explorer, Operative	EKB	1	Manufacturer	accessdata.fda.gov
File, Margin Finishing, Operative	EKA	1	Manufacturer	accessdata.fda.gov
File, Pulp Canal, Endodontic	EKS	1	Manufacturer	accessdata.fda.gov
Forceps, Rubber Dam Clamp	EJG	1	Manufacturer	accessdata.fda.gov
Gutta-Percha	EKM	1	Manufacturer	accessdata.fda.gov
Handle, Instrument, Dental	EJB	1	Manufacturer	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Manufacturer	accessdata.fda.gov
Knife, Periodontic	EMO	1	Manufacturer	accessdata.fda.gov
Mirror, Mouth	EAX	1	Manufacturer	accessdata.fda.gov
Needle, Dental	DZM	1	Manufacturer	accessdata.fda.gov
Pick, Massaging	JET	1	Manufacturer	accessdata.fda.gov
Pliers, Operative	EJY	1	Manufacturer	accessdata.fda.gov
Plugger, Root Canal, Endodontic	EKR	1	Manufacturer, Specification developer	accessdata.fda.gov
Post, Root Canal	ELR	1	Manufacturer	accessdata.fda.gov
Preparer, Root Canal Endodontic	EKQ	1	Manufacturer	accessdata.fda.gov
Probe, Periodontic	EIX	1	Manufacturer	accessdata.fda.gov
Resin, Root Canal Filling	KIF	2	Repackager or relabeler	accessdata.fda.gov
Retractor, All Types	EIG	1	Manufacturer	accessdata.fda.gov
Scissors, Surgical Tissue, Dental	EGN	1	Manufacturer	accessdata.fda.gov
Spreader, Pulp Canal Filling Material, Endodontic	EKK	1	Manufacturer	accessdata.fda.gov
Tester, Pulp	EAT	2	Manufacturer	accessdata.fda.gov
Tip, Rubber, Oral Hygiene	JEW	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 21, 2009	K090992	WELL-PASTE	KIF	Substantially Equivalent	Vericom Co., Ltd.	accessdata.fda.gov
June 5, 2006	K060347	B&L L-BETA, MODEL WL-B1	EKR	Substantially Equivalent	B&L Biotech Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 21, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.