Data / Medical devices / Israel / B.J.M. Laboratories Ltd
B.J.M. Laboratories Ltd: FDA-registered device maker in OR-YEHUDA Central, Israel, 21 510(k) clearances
B.J.M. Laboratories Ltd is registered with the FDA (registration 1000272892) in OR-YEHUDA Central, Israel. It lists 9 device types. The FDA files 21 510(k) clearances under its listings, the newest dated March 3, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000272892
- Address
- 12 Hasadna ST. Industrial Park, OR-YEHUDA Central, Israel, 6022011
- Owner or operator
- B.J.M. Laboratories Ltd (9057695)
- Roles
- Manufacturer
- First device listed
- January 15, 2009
- Registered through
- 2026
- Brand names listed
- Activ GP, BJM Root Canal Sealer, Biocoat Sealant, Block-Out Resin, Bond-PR Universal Adhesive, BondBoost SE, Cem-Implant, CompCore AF, Intro and Refill shades and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | 2 | Manufacturer | accessdata.fda.gov |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Manufacturer | accessdata.fda.gov |
| Agent, Tooth Bonding, Resin | KLE | 2 | Manufacturer | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Manufacturer | accessdata.fda.gov |
| Cord, Retraction | MVL | U | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | Manufacturer | accessdata.fda.gov |
| Sealant, Pit And Fissure, And Conditioner | EBC | 2 | Manufacturer | accessdata.fda.gov |
| Varnish, Cavity | LBH | 2 | 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 |
|---|---|---|---|---|---|---|
| March 3, 2026 | K260682 | Bond-PR Universal Adhesive | KLE | Substantially Equivalent | Premier Dental Products Company | accessdata.fda.gov |
| November 7, 2025 | K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite | EBF | Substantially Equivalent | Premier Dental Products Company | accessdata.fda.gov |
| December 6, 2022 | K223632 | Premier's MultiMatch Universal Chameleon Restorative Composite | EBF | Substantially Equivalent | Premier Dental Products Company | accessdata.fda.gov |
| January 28, 2022 | K213093 | STEP-1 PumEtch | KLE | Substantially Equivalent | Rounding Third, LLC | accessdata.fda.gov |
| July 31, 2017 | K170207 | Obturys | KIF | Substantially Equivalent | Itena Clinical | accessdata.fda.gov |
| October 18, 2016 | K161580 | Premier Sealant | EBC | Substantially Equivalent | Premier Dental Company Products | accessdata.fda.gov |
| July 22, 2015 | K150601 | Zeramic Adhesive Resin Cement | EMA | Substantially Equivalent | Premier Dental Company Products | accessdata.fda.gov |
| November 17, 2014 | K141839 | PREMIER ETCH | KLE | Substantially Equivalent | Premier Dental Products Co. | accessdata.fda.gov |
| August 26, 2013 | K131212 | PREMIER CERAMIC PRIMER | KLE | Substantially Equivalent | Premier Dental Products Co. | accessdata.fda.gov |
| April 19, 2013 | K121804 | PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM | EMA | Substantially Equivalent | Itena Clinical | accessdata.fda.gov |
| April 28, 2009 | K083695 | TRAXODENT | MVL | Substantially Equivalent | Premier Dental Products Co. | accessdata.fda.gov |
| October 4, 2006 | K061998 | PREMIER SELF-ETCHING BOND ENHANCER | KLE | Substantially Equivalent | Premier Dental Products Co. | accessdata.fda.gov |
| October 4, 2006 | K061997 | PREMIER SELF-ETCHING ENAMEL SEALANT | EBC | Substantially Equivalent | Premier Dental Products Co. | accessdata.fda.gov |
| September 6, 2005 | K051866 | PREMIER TEMPORARY CEMENT | EMA | Substantially Equivalent | Premier Dental Products Co. | accessdata.fda.gov |
| April 6, 2005 | K050750 | LC BRACKET ADHESIVE SYSTEM | DYH | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| September 21, 2004 | K042215 | RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT | EMA | Substantially Equivalent | Premier Dental Products Co. | accessdata.fda.gov |
| April 2, 2004 | K040375 | IDEAL 1 ORTHODONTIC BAND CEMENT | DYH | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| February 6, 2004 | K033703 | IDEAL 1 ORTHODONTIC BRACKET ADHESIVE | DYH | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| January 26, 2004 | K033309 | PREMIER IMPLANT CEMENT, MODEL 3001450 | EMA | Substantially Equivalent | Premier Dental Products Co. | accessdata.fda.gov |
| September 27, 2001 | K012160 | COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408 | EBF | Substantially Equivalent | Premier Dental Products Co. | accessdata.fda.gov |
| January 26, 1994 | K933766 | HIGH-Q-BOND | EBF | Substantially Equivalent | Silmet U.S.A. Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Resin, Root Canal Filling
- All makers of Sealant, Pit And Fissure, And Conditioner
- All makers of Cement, Dental
- All makers of Adhesive, Bracket And Tooth Conditioner, Resin
- All makers of Agent, Tooth Bonding, Resin
- All makers of Cord, Retraction
Updated March 3, 2026. 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.