Identity
- Trade Name
- myQuickmat Classico starter kit EUDAMEDFDA UDI
- Generic Name
- Dental matrix band kit FDA UDI
- Device Name
- myQuickmat Classico starter kit EUDAMED
- Model / Reference
- 6881 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- +E29968810 EUDAMEDE29968810 FDA UDI
- Basic UDI-DI
- ++E299MQCSKA7 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 matrix system for class II dental restoration 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
myQuickmat Classico starter 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 | ++E299MQCSKA7 | 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 28b422a4-5791-49aa-bf71-626f06817010 61 fields · synced Jul 11, 2026
- FDA UDI b8d162bc-65fb-424e-b108-82cf85cd4dc9 32 fields · synced May 26, 2026