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Dental Impression and prosthetic components
EUDAMEDFDA UDIClass I (EU MDR)
Ref 069476003001601EZ
Identity
- Trade Name
- Dental Impression and prosthetic components EUDAMEDImpression Post for open tray,for screw-retained abutment,abutment level FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- Dental Impression and prosthetic components EUDAMED
- Model / Reference
- 069476003001601EZ EUDAMED162710N FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06947600303787 EUDAMEDFDA UDI
- Basic UDI-DI
- 069476003001601EZ EUDAMED
- 510(k) Number
- K212364 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
- GMDN Term
- Dental implant system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Germany 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dental Impression and prosthetic components by BIO CONCEPT Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 069476003001601EZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bio Concept Co., Ltd.
- EUDAMED SRN
- CN-MF-000019318
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 41cf2f04-e718-4830-a6ad-12577fcb88e2 61 fields · synced Jul 19, 2026
- FDA UDI 389766cb-785a-4a99-8e1b-0fdb9972b1ee 33 fields · synced May 30, 2026