Registered with FDA
Zircon Plus Limited
Ramat Gan, Israel. Lists 11 dental device types with FDA across 1 registered establishment.
- Device types listed
- 11
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Israel
Devices listed with FDA
What Zircon Plus Limited currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | — | 2025 |
| Dental CementEMA · Class 2 | Dental cements | Lister | — | 2025 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | — | 2025 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | — | 2023 |
| X-Ray Film HolderEGZ · Class 1 | — | Lister | — | 2025 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Lister | — | 2025 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | — | 2025 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Lister | — | 2025 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Lister | — | 2025 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Lister | — | 2025 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Lister | — | 2025 |
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
Zircon Plus Limited 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: Dentsply Intl., Inc. (4), Kuraray Medical, Inc. (3), 3M Espe Dental Products (2), Dmg USA, Inc. (1), Espe Dental AG (1), Espe GmbH (Us) (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 30 Mar 2012 | K120379 | PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S | Kuraray Medical, Inc. | EMA Dental Cement |
| 19 Mar 2012 | K120453 | FILTEK BULK FILL FLOWABLE RESTORATIVE | 3M Espe Dental Products | EBF Resin Tooth Shade Material |
| 10 Mar 2010 | K092141 | VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH | 3M Espe Dental Products | LBH Cavity Varnish |
| 5 Mar 2010 | K100328 | CLEARFIL MAJETY POSTERIOR | Kuraray Medical, Inc. | EBF Resin Tooth Shade Material |
| 21 Mar 2007 | K070325 | CLEARFIL MAJESTY ESTHETIC PLT | Kuraray Medical, Inc. | EBF Resin Tooth Shade Material |
| 16 Jun 2004 | K040906 | CALIBRA CEMENT | Dentsply Intl., Inc. | EMA Dental Cement |
| 24 Jan 2002 | K013674 | LUXATEMP/LUXATEMP SOLAR/INSTATEMP | Dmg USA, Inc. | EBG Resin Temporary Crown and Bridge |
| 8 Sep 1999 | K992897 | IMPREGUM PENTA | Espe Dental AG | ELW Impression Material |
| 13 Jan 1999 | K984387 | R-30 AESTHETIC RESTORATIVE | Dentsply Intl., Inc. | EBF Resin Tooth Shade Material |
| 21 Sep 1998 | K982394 | PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM | Dentsply Intl., Inc. | KLE Resin Tooth Bonding Agent |
| 26 Apr 1996 | K960548 | AH PLUS ROOT CANAL SEALER | Dentsply Intl., Inc. | KIF Root Canal Filling Resin |
| 25 Mar 1985 | K844846 | ESPE KETAC-CEM RADIOPAQUE | Espe GmbH (Us) | EMA Dental Cement |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ZIRCON PLUS LIMITEDFDA reg. 3026400121 | Ramat Gan Central, Israel | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10087265). 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.