Identity
- Trade Name
- Unica master kit EUDAMEDFDA UDI
- Generic Name
- Dental matrix band kit FDA UDI
- Device Name
- Unica master kit EUDAMED
- Model / Reference
- 6901 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 6901 FDA UDI
- Primary DI / UDI-DI
- +E29969010 EUDAMEDE29969010 FDA UDI
- Basic UDI-DI
- ++E299UNICAMASTERKITV8 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
- GMDN Term
- Dental matrix band kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Medical Purpose
- Anterior matrix system EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Unica master kit by Polydentia SA — 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 | ++E299UNICAMASTERKITV8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Polydentia SA
- EUDAMED SRN
- CH-PR-000009114
Sources (2)
- EUDAMED 8741d57a-0d67-4ac1-8e31-7651845ba643 61 fields · synced Jul 9, 2026
- FDA UDI 46d71e3c-9ee7-4fe4-b041-1c655b06edf9 33 fields · synced May 27, 2026