Identity
- Trade Name
- DuraFinish™ FDA UDI
- Generic Name
- Dental unfilled resin sealant/coating FDA UDI
- Device Name
- DuraFinish™ Composite Glaze FDA UDI
- Model / Reference
- S295 FDA UDI
- Description
- DuraFinish™ Composite Glaze FDA UDI
Identifiers
- Catalog Number
- S295 FDA UDI
- Primary DI / UDI-DI
- 00810000525188 FDA UDI
- FDA Product Code
- EBD FDA UDI
- GMDN Term
- Dental unfilled resin sealant/coating FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3310 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
DuraFinish™ by Parkell, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Parkell, Inc.
Sources (1)
- FDA UDI f00152ae-9c3c-4f89-a5ae-51127c11371c 37 fields · synced May 30, 2026