BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    B&L BIOTECH CO., INC

    Reg #: 3005831677 · FEI: 3005831677 · Expires 2026
    View on FDA
    Products
    32
    Proprietary Names
    435
    Establishment Types
    3
    Classifications
    32

    Registration Details

    Registration Name
    B&L BIOTECH CO., INC
    Registration Number
    3005831677
    FEI Number
    3005831677
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    #421,#420, 453, Byeolmang-ro, Danwon-gu
    City
    Ansan City Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K060347

    Owner / Operator

    Firm Name
    B&L BIOTECH CO., LTD.
    Operator Number
    9082994
    Address
    #421,#420, 453, Byeolmang-ro,, Danwon-gu
    City
    Ansan-si
    State
    Gyeonggi
    Postal Code
    15599
    Country
    KR

    US Agent

    Business Name
    Kamm & Associates
    Contact Name
    Daniel Kamm
    Address
    8870 Ravello Ct
    City
    Naples
    State
    FL
    ZIP
    34114
    Country
    US
    Email
    [email protected]
    Phone
    847 3741727

    Products

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

    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 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 JIMM2 B&L Jetip Instrument Micro Mirror DMP4 DMHG PEM JX5H DMF4 Jet X Currette 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 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 WARMO PW-A1 WARMA PW-A2 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 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 JISC2 JE1JE2 JE3JE4 Endodontic Explorer & Periodontal Probe JEXJPP JTEE ENEX BSN2220 BMN2423 BSN2625 BSN2425 BSN2820 BSN2420 BSN2123 BSN2423 Beta BSN2823 BSN5020 BMN2425 BSN2225 CKN1 BMN2420 NCKE (NCK Needle EMS type) Needle Bender NCKA (NCK Needle SATELEC type) CK AP4 HSN2123 HotShot 21mm Needle, 23Gauge CA90-A CK AP8 CK AP7 CK AP1 HSN2823 HotShot 28mm Needle, 23Gauge CK AP3 CK AP2 HSN2820 HotShot 28mm Needle, 20Gauge HSN5020 HotShot 50mm Needle, 20Gauge - VET CK TT1 HSN2225 HotShot 22mm Needle, 25Gauge HSN2220 HotShot 22mm Needle, 20Gauge CAN90 CA90-E HMN2423 HotShot 24mm needle , 23Gauge (Multi bending) CK AP6 CKN90 HMN2425 HotShot 24mm needle , 25Gauge (Multi bending) CA120-E CA120-A CAN120 CK AP5 CK AP9 HMN2420 HotShot 24mm needle , 20Gauge (Multi bending) CK TT2 CK TT3 HSN2423 HotShot 24mm Needle, 23Gauge HSN2625 HotShot 26mm Needle, 25 Gauge HSN2420 HotShot 24mm Needle, 20Gauge HSN2425 HotShot 24mm Needle, 25 Gauge MTA Carrier JM3JM4 JETrac CLAMP12A CLAMP201 CLAMP13A CLAMP210 CLAMP211 CLAMP1 Rubber Dam Obtura Spartan Standard Spreader Obtura Spartan Narrow Spreader Alpha II Spreader SPRDN Alpha II Spreader SPRDS

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility