Identity
- Trade Name
- Polydentia matrix system trial kit FDA UDI
- Generic Name
- Dental matrix band kit FDA UDI
- Model / Reference
- 2103 FDA UDI
Identifiers
- Primary DI / UDI-DI
- E29921030 FDA UDI
- FDA Product Code
- DZN FDA UDI
- GMDN Term
- Dental matrix band kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA 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
Polydentia matrix system trial kit by Polydentia SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Polydentia SA
Sources (1)
- FDA UDI 958ebefa-8ca2-4ea5-9e38-339fa767bc55 33 fields · synced May 30, 2026