Zirkonzahn SRL
IT-MF-000028795 · Italy · Gais (BZ)
Zirkonzahn SRL is registered in the European database on medical devices as a manufacturer, with 480 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 401 |
|---|---|
| Class IIb | 79 |
Among these devices, 373 are declared implantable, 8 active, 8 with a measuring function.
Devices declared under this manufacturer
- ADAPTER RATCHET WRENCH
- ANATOMIC CLEAR PLUS COLOURED ILUME
- ANATOMIC CLEAR PLUS DISPERSIVE
- BLACKSTONE 3 ARTISTIC ILUME
- BLACKSTONE 3 PLUS ARTISTIC EXTRA ILUME
- COLOUR LIQUID PRETTAU AQUARELL BOOST
- CONEXOLOC ZIRCONIA ABUTMENT HEX COLOURED
- DENTURE GINGIVA PRO MULTISTRATUM
- SET CONEXOLOC BASE NON HEX COLOURED
- SET NARROW TI-BASE HEX
- TEMP PREMIUM FLEXIBLE
- VITA YZ ST SHADE LIQUID
Showing 12 of 480 declared devices.
Catalogue references include BSAPxx(x)yy(Lvv)(Kvv), DSCExx(x)yy(ww)(zzz(z)), EZ0CSxxxx(x), ZROOxxxxyyy, ZRSRxxxxyyy, ZSBPxxxxyyy.
European nomenclature codes declared: Q01020602, Q01020604, Q01020605, Q01010199, Q0102050199, Q010280.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ZIRKONZAHN SRL (IT) · FDA 3005904906 |
| Devices in EUDAMED | 480 |
| Country of registration | Italy |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ZIRKONZAHN SRL |
What it holds in Canada
| Licences on record | 21 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 8 |
| Class 3 devices | 13 |
| First licensed | 2009-04-03 |
Licence types: Device Family (15), System (5), Single Device (1).
Licensed under: ICE ZIRCON DENTAL PORCELAIN SYSTEM, THERAPON TRANSPA, TITAN AND CHROM-COBALT, TEMP BASIC TRANSPA, TEMP PREMIUM FLEXIBLE AND MULTISTRATUM FLEXIBL, SINTERMETALL.
North American profile: Both markets. Zirkonzahn SRL is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
207/MDR | supplemented | 2030-03-24 |