Identity
- Trade Name
- myQuickmat All-round introkit EUDAMEDFDA UDI
- Generic Name
- Dental matrix band kit FDA UDI
- Device Name
- myQuickmat All-round introkit EUDAMED
- Model / Reference
- 6850 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- +E29968500 EUDAMEDE29968500 FDA UDI
- Basic UDI-DI
- ++E299MQARIK8E 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
- Circumferential matrix system for posterior dental 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
myQuickmat All-round introkit 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 | ++E299MQARIK8E | 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 15b21a67-cabd-447d-8696-b648558e5221 61 fields · synced Jul 21, 2026
- FDA UDI 44f0771b-8b7d-451d-8bce-7c8c617a45b4 32 fields · synced May 30, 2026