Data / Medical devices / Israel / Zircon Plus Limited
Zircon Plus Limited: FDA-registered device maker in Ramat Gan Central, Israel, 12 510(k) clearances
Zircon Plus Limited is registered with the FDA (registration 3026400121) in Ramat Gan Central, Israel. It lists 11 device types. The FDA files 12 510(k) clearances under its listings, the newest dated March 30, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026400121
- Address
- MENDEL MATITYAHU 7 Suite 1, Ramat Gan Central, Israel, 528704
- Owner or operator
- ZIRCON PLUS LIMITED (10087265)
- Roles
- Exporter to the US
- First device listed
- February 6, 2023
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Exporter to the US | accessdata.fda.gov |
| Agent, Tooth Bonding, Resin | KLE | 2 | Exporter to the US | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Exporter to the US | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Exporter to the US | accessdata.fda.gov |
| Holder, Film, X-Ray | EGZ | 1 | Exporter to the US | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Exporter to the US | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Exporter to the US | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Exporter to the US | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | Exporter to the US | accessdata.fda.gov |
| Scaler, Periodontic | EMN | 1 | Exporter to the US | accessdata.fda.gov |
| Varnish, Cavity | LBH | 2 | Exporter to the US | 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 30, 2012 | K120379 | PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S | EMA | Substantially Equivalent | Kuraray Medical, Inc. | accessdata.fda.gov |
| March 19, 2012 | K120453 | FILTEK BULK FILL FLOWABLE RESTORATIVE | EBF | Substantially Equivalent | 3M Espe Dental Products | accessdata.fda.gov |
| March 10, 2010 | K092141 | VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH | LBH | Substantially Equivalent | 3M Espe Dental Products | accessdata.fda.gov |
| March 5, 2010 | K100328 | CLEARFIL MAJETY POSTERIOR | EBF | Substantially Equivalent | Kuraray Medical, Inc. | accessdata.fda.gov |
| March 21, 2007 | K070325 | CLEARFIL MAJESTY ESTHETIC PLT | EBF | Substantially Equivalent | Kuraray Medical, Inc. | accessdata.fda.gov |
| June 16, 2004 | K040906 | CALIBRA CEMENT | EMA | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| January 24, 2002 | K013674 | LUXATEMP/LUXATEMP SOLAR/INSTATEMP | EBG | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
| September 8, 1999 | K992897 | IMPREGUM PENTA | ELW | Substantially Equivalent | Espe Dental AG | accessdata.fda.gov |
| January 13, 1999 | K984387 | R-30 AESTHETIC RESTORATIVE | EBF | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| September 21, 1998 | K982394 | PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM | KLE | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| April 26, 1996 | K960548 | AH PLUS ROOT CANAL SEALER | KIF | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| March 25, 1985 | K844846 | ESPE KETAC-CEM RADIOPAQUE | EMA | Substantially Equivalent | Espe GmbH (Us) | accessdata.fda.gov |
Compare with other makers
- All makers of Material, Tooth Shade, Resin
- All makers of Cement, Dental
- All makers of Instruments, Dental Hand
- All makers of Resin, Root Canal Filling
- All makers of Agent, Tooth Bonding, Resin
- All makers of Agent, Polishing, Abrasive, Oral Cavity
Updated March 30, 2012. 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.