Identity
- Trade Name
- Uni-Wedge, Regular FDA UDI
- Generic Name
- Dental wedge, single-use FDA UDI
- Device Name
- The Uni-Wedge is a plastic wedge that is meant to replace standard wooden wedges. The Uni-Wedges are flexible, made of plastic and will not break or splinter. Designed with finder grips to facilitate use. Each box contains 250 wedges. FDA UDI
- Model / Reference
- 93852 FDA UDI
- Description
- The Uni-Wedge is a plastic wedge that is meant to replace standard wooden wedges. The Uni-Wedges are flexible, made of plastic and will not break or splinter. Designed with finder grips to facilitate use. Each box contains 250 wedges. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D876938521 FDA UDI
- FDA Product Code
- EIF 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental wedge, single-use
Uni-Wedge, Regular by Almore International Inc — 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
- Almore International Inc
Sources (1)
- FDA UDI 611c0b13-0581-4d93-a624-b547bae5e0ca 33 fields · synced May 31, 2026