Dental Device Guide
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Manufacturer registered with FDA

B&L Biotech Co., Ltd.

Ansan-si, South Korea. Lists 32 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator9082994ManufacturerRepacker / relabelerSpecification developer
Device types listed
32
Brands and models
445
510(k) clearances
12006–2006
Markets registered in
36 registrations outside the US
Establishments
1South Korea
2006: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 3 markets

Where regulators' registries name B&L Biotech Co., Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 32 device types listedTaiwan: 5 registrationsIsrael: 1 registrations
RegisteredHome: South KoreaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerB&L Biotech Co., Ltd.1 clearances2006–2006Below
TaiwanTFDAManufacturerB&L BIOTECH, INCB&L BIOTECH INC.52010–2020Pure Global AI
IsraelAMARManufacturerB&L Biotech Inc.1—Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What B&L Biotech Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Endodontic Root Canal PluggerEKR · Class 1Dental hand instrumentsMaker
AC adaptor protector capAlphaAlpha EnclosureAlpha IIAlpha II CL-A1Alpha II Plugger BP3504Alpha II Plugger BP4004Alpha II Plugger BP4504Alpha II Plugger BP5004Alpha II Plugger BP5506
92 more
Alpha II Plugger BP5508Alpha II Plugger BP5508LAlpha II Plugger BP5510Alpha II Plugger BP6012AP-A1 Alpha PlusB&L Alpha II Starter Kit (Black) ASKBB&L Alpha II Starter Kit (Pink) ASKPB&L Alpha II Starter Kit (White) ASKWB&L Beta Starter Kit (Black) BSKBB&L Beta Starter Kit (Pink) BSKPB&L Beta Starter Kit (White) BSKWBall Burnisher & Micro plugger JB2JP3Beta Mini Starter Kit (Black) ESKBBeta Mini Starter Kit (Pink) ESKPBeta Mini Starter Kit (White) ESKWBKX10T BL-B Kondenser (100)BKX12T BL-B Kondenser (120)BKX35 BL-B Kondenser (35/70)BKX35L BL-B Kondenser Long (35/70)BKX35LT BL-B Kondenser Long (35)BKX35T BL-B Kondenser (35)BKX40 BL-B Kondenser (40/80)BKX40L BL-B Kondenser Long (40/80)BKX40LT BL-B Kondenser Long (40)BKX40T BL-B Kondenser (40)BKX50 BL-B Kondenser (50/100)BKX50L BL-B Kondenser Long (50/100)BKX50LT BL-B Kondenser Long (50)BKX50T BL-B Kondenser (50)BKX60 BL-B Kondenser (60/120)BKX60L BL-B Kondenser Long (60/120)BKX60LT BL-B Kondenser Long (60)BKX60T BL-B Kondenser (60)BKX70T BL-B Kondenser (70)BKX80T BL-B Kondenser (80)BKXSET BL-B Kondenser Set(35/70, 40/80, 50/100, 60/120)BKXSETL BL-B Kondenser Long Set (35/70, 40/80, 50/100, 60/120)BL-Condenser (various model #s)BL-S Kondenser 35/70BL-S Kondenser 35/70-LBL-S Kondenser 40/80BL-S Kondenser 40/80-LBL-S Kondenser 50/100BL-S Kondenser 50/100-LBL-S Kondenser 60/120BL-S Kondenser 60/120-LBL-S Kondenser L SETBL-S Kondenser SETBP-B1 Beta MiniBP3004BP3504BP4004BP4504BP5004BP5506BP5508BP5508LBP5510BP6012BPANCL-A1 B&L-Alpha IIHHTT Hot Testing TipHotshot BP-B1Hotshot BP-B1 Beta MiniHottip Alpha II CL-A1Hottip CL-A1HT3004 30/04 taper PluggerHT3504 35/04 taper PluggerHT4004 40/04 taper PluggerHT4504 45/04 taper PluggerHT5004 50/04 taper PluggerHT5506 55/06 taper pluggerHT5508 55/08 taper pluggerHT5508L 55/08 taper plugger long typeHT5510 55/10 taper pluggerHT6012 60/12 taper plugerHTTMicro plugger JP6JP7Obtura MaxPack SystemObtura Spartan 35/4 taper PluggerObtura Spartan 40/4 taper PluggerObtura Spartan 45/4 taper PluggerObtura Spartan 55/.10 taper PluggerObtura Spartan 55/6 taper PluggerObtura Spartan 55/8 taper PluggerObtura Spartan 60/.12 taper PluggerSilicone CoverSPRDNSPRDSThermal Protector CapsWL-B1 B&L BetaWL-B1 B&L-Beta
2006
Dental NeedleDZM · Class 1Dental needles & syringesMaker
BetaBMN2420BMN2423BMN2425BSN2123BSN2220BSN2225BSN2420BSN2423BSN2425
40 more
BSN2625BSN2820BSN2823BSN5020CA120-ACA120-ECA90-ACA90-ECAN120CAN90CK AP1CK AP2CK AP3CK AP4CK AP5CK AP6CK AP7CK AP8CK AP9CK TT1CK TT2CK TT3CKN1CKN90HMN2420 HotShot 24mm needle , 20Gauge (Multi bending)HMN2423 HotShot 24mm needle , 23Gauge (Multi bending)HMN2425 HotShot 24mm needle , 25Gauge (Multi bending)HSN2123 HotShot 21mm Needle, 23GaugeHSN2220 HotShot 22mm Needle, 20GaugeHSN2225 HotShot 22mm Needle, 25GaugeHSN2420 HotShot 24mm Needle, 20GaugeHSN2423 HotShot 24mm Needle, 23GaugeHSN2425 HotShot 24mm Needle, 25 GaugeHSN2625 HotShot 26mm Needle, 25 GaugeHSN2820 HotShot 28mm Needle, 20GaugeHSN2823 HotShot 28mm Needle, 23GaugeHSN5020 HotShot 50mm Needle, 20Gauge - VETNCKA (NCK Needle SATELEC type)NCKE (NCK Needle EMS type)Needle Bender
2011
Dental Hand InstrumentsDZN · Class 1Dental hand instrumentsMaker
B&L JetipB&L Jetip Instrument CatroviejoB&L MTA PalletJet X ChangeJISSB (B&L Jetip Instrument Surgical Basic Set)JISSE (B&L Jetip Instrument Essential Set)JISSS (B&L Jetip Instrument Surgical Suture Set)Microsurgical Instrument Tip JM1JM2TJISSB (B&L Titanium Jetip Instrument Surgical Basic Set)TJISSE (B&L Titanium Jetip Instrument Essential Set)
2011
Pulp TesterEAT · Class 2—Maker
Obtura Spartan Hot Pulp Testing Tip
2018
Mouth MirrorEAX · Class 1Dental hand instrumentsMaker
B&L Jetip Instrument Micro MirrorB&L MirrorDMF4DMHGDMP4JETip InstrumentJIMM2JX5HPEM
2010
Dental Surgical Tissue ScissorsEGN · Class 1Dental hand instrumentsMaker
B&L Jetip
2011
Rubber DamEIE · Class 1Rubber dam systemsMaker
Rubber Dam
2020
All Types RetractorEIG · Class 1Dental hand instrumentsMaker
JETrac
2010
Periodontic ProbeEIX · Class 1Dental hand instrumentsMaker
Endodontic Explorer & Periodontal Probe JEXJPP
2024
Dental Instrument HandleEJB · Class 1Dental hand instrumentsMaker
JETip InstrumentJIHBJIHGJIHSJIHYJXHBJXHGJXHSJXHY
2010
Rubber Dam Clamp ForcepsEJG · Class 1Rubber dam systemsMaker
CLAMP1CLAMP12ACLAMP13ACLAMP201CLAMP210CLAMP211
2025
Dental BurEJL · Class 1Dental burs & diamondsMaker
PT-1APT-1EPT-2APT-2EPT-3APT-3E
2024
Operative PliersEJY · Class 1Dental hand instrumentsMaker
B&L Jetip
2011
Operative Margin Finishing FileEKA · Class 1Dental hand instrumentsMaker
BLPOT-BPFBBLPOT-BPFGBLPOT-BPFPBLPOT-BPFS3BLPOT-BPFS5
2019
Operative ExplorerEKB · Class 1Dental hand instrumentsMaker
ENEXJETip InstrumentJTEE
2010
Operative Dental ExcavatorEKC · Class 1Dental hand instrumentsMaker
JETip Instrument
2010
Operative Amalgam CarrierEKI · Class 1Dental hand instrumentsMaker
MTA Carrier JM3JM4
2024
Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1Dental hand instrumentsMaker
Alpha II Spreader SPRDNAlpha II Spreader SPRDSObtura Spartan Narrow SpreaderObtura Spartan Standard Spreader
2018
Gutta-PerchaEKM · Class 1Root canal filling materialsMaker
B&L GP Gauge & Cutter- GGACB&L Gutta percha
2012
Root Canal Endodontic PreparerEKQ · Class 1Endodontic filesMaker
B&L Paper Point
2012
Endodontic Pulp Canal FileEKS · Class 1Endodontic filesMaker
CI120-ACI120-ECI90-ACI90-ECIF120CIF90DGR Digital RulerEMSET1EMSET2EMSET3
91 more
EMSET4EMSET5EMSET6EMSET7EMSET8ENBMBENBRBLENBRBL (Endo Bracelet Black Large)ENBRBSENBRBS (Endo Bracelet Black Small)ENBRGL (Endo Bracelet Gray Large)ENBRGS (Endo Bracelet Gray Small)ENBRLENBRLLENBRLRENBSLLENBSLRENBSPENBSSLENBSSRENMMB1-L Endo M Main Body DLC Left (1EA)ENMMB1-R Endo M Main Body DLC Right (1EA)ENMMB10-L Endo M Main Body DLC Left (10EA)ENMMB10-R Endo M Main Body DLC Right (10EA)ENMMB2-L Endo M Main Body DLC Left (2EA)ENMMB2-R Endo M Main Body DLC Right (2EA)ENMMB3-L Endo M Main Body DLC Left (3EA)ENMMB3-R Endo M Main Body DLC Right (3EA)ENMMB6-L Endo M Main Body DLC Left (6EA)ENMMB6-R Endo M Main Body DLC Right (6EA)ENMMBR2ENMMBRBENMMGBENMMGDENMRDLENMRDMENMRDSENMSLB-LENMSLB-RENMSLG-LENMSLG-RENMSSB-LENMSSB-RENMSSG-LENMSSG-RENRML: Endo Ring LargeENRMS: Endo Ring SmallERMBL: Endo Ring Main Body LeftERMBR: Endo Ring Main Body RightERMGN: Endo Ring MagneticERSET1ERSET10ERSET11ERSET12ERSET2ERSET3ERSET4ERSET5ERSET6ERSET7ERSET8ERSET9INF20INF25INF30INF35MRSET1MRSET10MRSET11MRSET12MRSET13MRSET14MRSET15MRSET16MRSET17MRSET18MRSET19MRSET2MRSET20MRSET21MRSET22MRSET23MRSET24MRSET3MRSET4MRSET5MRSET6MRSET7MRSET8MRSET9Product Name
2011
Endodontic CuretteEKT · Class 1Dental hand instrumentsMaker
JC13JC14Jet X CurretteJETip InstrumentJX1JX2
2010
Root Canal PostELR · Class 1Root canal filling materialsMaker
Z.Post
2009
Dental Surgical ElevatorEMJ · Class 1Dental hand instrumentsMaker
JE1JE2JE3JE4JETip InstrumentJISC2
2010
Dental Surgical CuretteEMK · Class 1Dental hand instrumentsMaker
Curette Scaler (Left) JXCSLCurette Scaler (Right) JXCSRHorse Currette (Left) JXHCLHorse Currette (Right) JXHCRJETip InstrumentJetXchange Curette half (1 tip) JXCC4LYJetXchange Curette half (1 tip) JXCC4RYJetXchange Curette half (1 tip) JXCDH5GJetXchange Curette half (1 tip) JXCG11NJetXchange Curette half (1 tip) JXCG12N
22 more
JetXchange Curette half (1 tip) JXCG13BJetXchange Curette half (1 tip) JXCG14BJetXchange Curette half (1 tip) JXCJ33GJetXchange Curette JXCBBJetXchange Curette JXCGGJetXchange Curette JXCNNJetXchange Curette JXCYYLarge Gracey Curette JXLG1Large Gracey Curette JXLG2Mini Gracey Curette JXMG1Mini Gracey Curette JXMG2Mini Gracy Curette JC1JC2Mini Gracy Curette JC3JC4Molt Curette Offset (Left & Right) JC15JC16Molt Curette Offset (Left) JXMCLMolt Curette Offset (Right) JXMCRSurgical Curete Offset (Left) JXSCLSurgical Curete Offset (Right) JXSCRSurgical Curette Offset (Left & Right) JC15JC16Surgical Curette Straight JC9JC10Surgical Curette Straight JXSC1Surgical Curette Straight JXSC2
2010
Periodontic KnifeEMO · Class 1Dental hand instrumentsMaker
Leetrac (Narrow handle) LTNNSLeetrac (Wide handle) LTRNSLeetrac Blade protrude 1 LTNBPLeetrac Blade protrude 2 LTNBQLeetrac Blade rectangle LTNBSLeetrac Blade rectangle LTRBSLeetrac Blade rectangle small LTSBSLeetrac Blade round LTNBRLeetrac Blade round LTRBRLeetrac Blade small rectangle LTNBT
3 more
Leetrac Blade trapezium LTRBTLeetrac handle LRNNHLeetrac handle LRTNH
2018
Massaging PickJET · Class 1Floss & interdental cleanersMaker
BL TipBL-1-ABL-3-ABL-5-ABLSKACK tipCSACSEDB-0ADB-0E
38 more
DB-3ADB-3EDS-LADS-LEDS-RADS-REDS-SADS-SEDS-XADS-XEDS-XLADS-XLEDS-XRADS-XREHot Testing Tip HTTIS TipJETipJT-2B-AJT-2L-AJT-2R-AJT-2S-AJTEFAPVSAPVSBAPVSBEPVSCPVSES tipSTS-5ATS-LATS-LETS-RATS-RETS-SATS-SEVibra Post TipVP-AZ.Post
2009
Oral Hygiene Rubber TipJEW · Class 1Floss & interdental cleanersMaker
JETip
2010
Root Canal Filling ResinKIF · Class 2Root canal filling materialsLister
Well-Paste
2010
Resin ApplicatorKXR · Class 1—Maker
COMONGR#1NGR#2POMO
2016
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker
KimTracKTN1NKTN1SKTN2NKTN2SKTN3NKTN3SKTN4NKTN4SKTNNH
9 more
KTNNSKTNSSLeetracLTNBRLTNMLLTNMSLTRMLLTRMSLTSBR
2011
Composite Resin WarmerQGO · Class 1—Maker
WARMA PW-A2WARMO PW-A1
2025

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names B&L Biotech Co., Ltd. as the applicant.

Decided510(k)DeviceDevice type
5 Jun 2006K060347B&L L-BETA, MODEL WL-B1EKR Endodontic Root Canal Plugger

Some of these clearances are listed with FDA today by another company: Young Innovations Inc (1).

Also lists devices cleared under other names

B&L Biotech Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Vericom Co., Ltd. (1).

Decided510(k)DeviceApplicantDevice type
21 Apr 2009K090992WELL-PASTEVericom Co., Ltd.KIF Root Canal Filling Resin

Registered establishments

EstablishmentLocationWhat it does
B&L BIOTECH CO., INCFDA reg. 3005831677Ansan City Gyeonggi, South KoreaManufacturer, Repacker / relabeler, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9082994). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.