Identity
- Trade Name
- GC Initial Zirconia Disk Multilayer Elite EUDAMEDGC Initial Zirconia Disk FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- Dental restorative devices EUDAMED
- Model / Reference
- 70017446 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04251366914579 EUDAMEDFDA UDI
- Basic UDI-DI
- 42513669ZRO2RQ EUDAMED
- 510(k) Number
- K100250 FDA UDI
- FDA Product Code
- EIH FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Dental appliance fabrication material, ceramic
GC Initial Zirconia Disk by Pritidenta GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K100250 also covers:
- GC Initial Zirconia Disk — Pritidenta GmbH
- GC Initial Zirconia Disk — Pritidenta GmbH
- GC Initial Zirconia Disk — Pritidenta GmbH
- GC Initial Zirconia Disk — Pritidenta GmbH
- GC Initial Zirconia Disk — Pritidenta GmbH
- GC Initial Zirconia Disk — Pritidenta GmbH
- GC Initial Zirconia Disk — Pritidenta GmbH
- GC Initial Zirconia Disk — Pritidenta GmbH
- SIN Zirconia — Pritidenta GmbH
- SIN Zirconia — Pritidenta GmbH
- SIN Zirconia — Pritidenta GmbH
- SIN Zirconia — Pritidenta GmbH
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- Pritidenta GmbH
Sources (2)
- FDA UDI 3c02bf91-e67f-43f3-9b3b-cdb9927d4691 33 fields · synced Jul 25, 2026
- EUDAMED d284f97e-e610-4c54-b8eb-b5a01f341e91 61 fields · synced Jul 25, 2026