Manufacturer registered with FDA
B.J.M. Laboratories Ltd
Or-Yehuda, Israel. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 70
- 510(k) clearances
- 0as applicant
- Markets registered in
- 760 registrations outside the US
- Establishments
- 1Israel
Registered in 7 markets
Where regulators' registries name B.J.M. Laboratories Ltd as the manufacturer or the registration holder of a device.
RegisteredHome: IsraelOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | B.J.M. Laboratories Ltd | 8 device types | — | Below |
| South Korea | MFDS | Manufacturer | B.J.M. Laboratories Ltd.B.J.M Laboratories Ltd. · B.J.M Laboratories Ltd · +2 | 23 | 2008–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | B.J.M. Laboratories Ltd. | 15 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | B.J.M. LABORATORIES LTDBJM LABORATORIES LTD | 9 | 2024–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | B.J.M. Laboratories Ltd. | 6 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | B.J.M. LABORATORIES LTD.B.J.M LABORATORIES LTD. | 5 | 2020–2024 | Pure Global AI |
| China | NMPA | Registration holder | 碧杰美实验室有限公司B.J.M.LABORATORIES LTD. | 2 | — | 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.J.M. Laboratories Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental CementEMA · Class 2 | Dental cements | Maker | Activ GPCem-ImplantDentoCemHigh-Q-BondHigh-Q-Bond SEHigh-Q-Bond SE Adhesive Resin CementPremier EndoCemPremier Implant CementPREMIER NEXTEMP TEMPORARY CEMENTQ-Glass Endo 4 moreQ-TEMPTotalCemZeramic Adhesive Resin CementZirconite Adhesive Resin Cement | 2012 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | Bond-PR Universal AdhesiveBondBoost SEPremier Ceramic PrimerPremier EtchPRIMA Quick PrimePRIMA SE PrimerQ-CeramQ-EtchSpot-On EtchSTEP-1 PumEtch Resin Tooth Bonding Agent 1 moreUNI-Q-Bond Universal Bonding Agent | 2012 |
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Maker | HIGH-Q-BONDHIGH-Q-BOND BAND CEMENTHIGH-Q-BOND BRACKET ADHESIVEHIGH-Q-BOND BRACKET comprising PRIMER, LIGHT CURE ADHESIVE, ETCHANTHIGH-Q-BOND BRACKET LIGHT CURE ADHESIVE IN COMPULESHIGH-Q-BOND BRACKET PRIMERHIGH-Q-BOND LINGUAL RETAINERIDEAL 1 Band Cement KitIDEAL 1 Bracket Adhesive SystemIDEAL 1 Kit comprising Bracket Adhesive, Primer, Band Cement; Refills 8 moreIDEAL 1 SE PrimerMultiMatch Flow Chameleon AntiMicrobial CompositeNEOBANDNEOBONDNEOBOND comprising GEL ETCH, PRIMER, PASTE SYRINGENEOBOND COMPULESNEOBOND JR. KITQ-ETCH ORTHO | 2012 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Block-Out ResinCompCore AF, Intro and Refill shadesHIGH-Q-BONDHIQ-Q-BOND SEIntegraBond Adhesive System, Bond 4ml and 7 ml, Activator and EtchantIntegraCem / Bond System, Base and CatalystMULTIBONDMultiMatch Flow Chameleon AntiMicrobial CompositePERFECTAPORCELAIN FIX comprising ETCH and SILANE 6 morePremier's MultiMatch Universal Chameleon Restorative CompositePRIMA 2000, PRIMA Quick, PRIMA SE, PRIMA 1, Auto-Cure Activator, Q-ETCH, Q-ETCH UFQ-CERAMQ-CORE, Q-CORE SyringableQ-Match Universal Restorative CompositeZIRCONITE | 2009 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Maker | Biocoat SealantEnamel LocMultiMatch Flow Chameleon AntiMicrobial CompositePremier Self-Etching Enamel SealantQ-SEALQUICK SEAL | 2012 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | STEP-1 PumEtch Resin Tooth Bonding Agent | 2022 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | BJM Root Canal SealerObturys | 2026 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | Bond-PR Universal AdhesiveUNI-Q-Bond Universal Bonding Agent | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
B.J.M. Laboratories 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: Premier Dental Products Company (11), Dentsply Intl., Inc. (3), ITENA Clinical (2), Premier Dental Company Products (2), Rounding Third, LLC (1), Silmet U.S.A. Corp. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 3 Mar 2026 | K260682 | Bond-PR Universal Adhesive | Premier Dental Products Company | KLE Resin Tooth Bonding Agent |
| 7 Nov 2025 | K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company | EBF Resin Tooth Shade Material |
| 6 Dec 2022 | K223632 | Premier's MultiMatch Universal Chameleon Restorative Composite | Premier Dental Products Company | EBF Resin Tooth Shade Material |
| 28 Jan 2022 | K213093 | STEP-1 PumEtch | Rounding Third, LLC | KLE Resin Tooth Bonding Agent |
| 31 Jul 2017 | K170207 | Obturys | ITENA Clinical | KIF Root Canal Filling Resin |
| 18 Oct 2016 | K161580 | Premier Sealant | Premier Dental Company Products | EBC Pit and Fissure Sealant and Conditioner |
| 22 Jul 2015 | K150601 | Zeramic Adhesive Resin Cement | Premier Dental Company Products | EMA Dental Cement |
| 17 Nov 2014 | K141839 | PREMIER ETCH | Premier Dental Products Company | KLE Resin Tooth Bonding Agent |
| 26 Aug 2013 | K131212 | PREMIER CERAMIC PRIMER | Premier Dental Products Company | KLE Resin Tooth Bonding Agent |
| 19 Apr 2013 | K121804 | PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM | ITENA Clinical | EMA Dental Cement |
| 4 Oct 2006 | K061998 | PREMIER SELF-ETCHING BOND ENHANCER | Premier Dental Products Company | KLE Resin Tooth Bonding Agent |
| 4 Oct 2006 | K061997 | PREMIER SELF-ETCHING ENAMEL SEALANT | Premier Dental Products Company | EBC Pit and Fissure Sealant and Conditioner |
| 6 Sep 2005 | K051866 | PREMIER TEMPORARY CEMENT | Premier Dental Products Company | EMA Dental Cement |
| 6 Apr 2005 | K050750 | LC BRACKET ADHESIVE SYSTEM | Dentsply Intl., Inc. | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 21 Sep 2004 | K042215 | RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT | Premier Dental Products Company | EMA Dental Cement |
| 2 Apr 2004 | K040375 | IDEAL 1 ORTHODONTIC BAND CEMENT | Dentsply Intl., Inc. | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 6 Feb 2004 | K033703 | IDEAL 1 ORTHODONTIC BRACKET ADHESIVE | Dentsply Intl., Inc. | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 26 Jan 2004 | K033309 | PREMIER IMPLANT CEMENT, MODEL 3001450 | Premier Dental Products Company | EMA Dental Cement |
| 27 Sep 2001 | K012160 | COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408 | Premier Dental Products Company | EBF Resin Tooth Shade Material |
| 26 Jan 1994 | K933766 | HIGH-Q-BOND | Silmet U.S.A. Corp. | EBF Resin Tooth Shade Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| B.J.M. LABORATORIES LTDFDA reg. 1000272892 | OR-YEHUDA Central, Israel | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9057695). 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.