Identity
- Trade Name
- FenderMate FDA UDI
- Generic Name
- Dental wedge, single-use FDA UDI
- Model / Reference
- D-coat Right Regular FDA UDI
Identifiers
- Catalog Number
- 602992 FDA UDI
- Primary DI / UDI-DI
- 17310236029929 FDA UDI
- FDA Product Code
- JEP FDA UDI
- GMDN Term
- Dental wedge, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental wedge, single-use
FenderMate by Directa AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Directa AB
Sources (1)
- FDA UDI aded6c7d-c236-4a8d-b4c4-0c8543f0b06e 33 fields · synced Jun 1, 2026