← Back to catalogue
Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank FDA UDI
- Generic Name
- Dental appliance fabrication material, combination-material FDA UDI
- Model / Reference
- SHT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975018580124 FDA UDI
- 510(k) Number
- K212259 FDA UDI
- FDA Product Code
- EIH FDA UDI
- GMDN Term
- Dental appliance fabrication material, combination-material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental appliance fabrication material, combination-material
Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank by Zirdent New Material Co., Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Dental appliance fabrication material, combination-material.
- Dental Lithium Disilicate Glass Ceramic — Liaoning Rachcera Material Technology Co., Ltd. · Class II
- 3Delta UNlimited — DeltaMed GmbH · Class II
- Dental Lithium Disilicate Glass Ceramic — Liaoning Rachcera Material Technology Co., Ltd. · Class II
- Dental Lithium Disilicate Glass Ceramic — Liaoning Rachcera Material Technology Co., Ltd. · Class II
- Dental Lithium Disilicate Glass Ceramic — Liaoning Rachcera Material Technology Co., Ltd. · Class II
- Dental Lithium Disilicate Glass Ceramic — Liaoning Rachcera Material Technology Co., Ltd. · Class II
- Dental Lithium Disilicate Glass Ceramic — Liaoning Rachcera Material Technology Co., Ltd. · Class II
- Dental Lithium Disilicate Glass Ceramic — Liaoning Rachcera Material Technology Co., Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zirdent New Material Co., Ltd
Sources (2)
- FDA UDI 328cb80e-445b-4bf0-9a2b-c49a911f6915 33 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026