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Dental Impression and prosthetic components
EUDAMEDFDA UDIClass I (EU MDR)
Ref 069476003001601EZ
Identity
- Trade Name
- Dental Impression and prosthetic components EUDAMEDRC Impression Post Opened Tray, with guide screw FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- Dental Impression and prosthetic components EUDAMED
- Model / Reference
- 069476003001601EZ EUDAMED162100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06947600307297 EUDAMEDFDA UDI
- Basic UDI-DI
- 069476003001601EZ EUDAMED
- 510(k) Number
- K150388 FDA UDI
- FDA Product Code
- DZE 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
- 872.3640 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization 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 de142cee-984d-485d-bfec-6f0ffb9ce1df 61 fields · synced Sep 17, 2026
- FDA UDI 71e380bc-1219-4f36-82cb-b21fcc9c6096 33 fields · synced May 30, 2026