Identity
- Trade Name
- Quickmat deluxe kit EUDAMEDFDA UDI
- Generic Name
- Dental matrix band kit FDA UDI
- Device Name
- Quickmat deluxe EUDAMED
- Model / Reference
- 5701 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- +E29957010 EUDAMEDE29957010 FDA UDI
- Basic UDI-DI
- ++E299QDKV4 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
- Sectional matrices kit for class II restorations EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Quickmat deluxe 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 | ++E299QDKV4 | 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 6954eb09-9de5-4a14-a9b2-fe148b2e7e81 61 fields · synced Jun 18, 2026
- FDA UDI afb098ea-8dee-4203-9b1a-d79891df8047 32 fields · synced May 30, 2026