Identity
- Trade Name
- sectional restorative trial set EUDAMEDFDA UDI
- Generic Name
- Dental matrix band kit FDA UDI
- Device Name
- sectional restorative trial set EUDAMED
- Model / Reference
- 1092 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- +E29910920 EUDAMEDE29910920 FDA UDI
- Basic UDI-DI
- ++E299SRTSL7 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 and wedges for class II dental restoration 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
sectional restorative trial set 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 | ++E299SRTSL7 | 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 a94929d2-9f26-4d2a-b251-40b0ae0972b4 61 fields · synced Jul 24, 2026
- FDA UDI 7601fa71-84e0-4db9-87a8-c1effcfafdd8 32 fields · synced May 30, 2026