Identity
- Trade Name
- DE corematrix FDA UDI
- Generic Name
- Dental porcelain/ceramic restoration kit FDA UDI
- Device Name
- Zirconia Dental Ceramics EUDAMED
- Model / Reference
- MDR EUDAMEDCMC/CMW FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974208580005 EUDAMEDFDA UDI
- Basic UDI-DI
- 697420858DECMWKE EUDAMED
- 510(k) Number
- K192262 FDA UDI
- FDA Product Code
- EIH FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental porcelain/ceramic restoration kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental porcelain/ceramic restoration kit
DE corematrix by De Corematrix Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- De Corematrix Co., Ltd.
Sources (2)
- FDA UDI 4b967f55-85d3-48a9-bd4b-88861dde6d6b 33 fields · synced Jun 18, 2026
- EUDAMED 80f624de-a5fc-4ee6-82eb-fb3531f313e0 61 fields · synced Jun 18, 2026