Identity
- Trade Name
- ACUWEDGE FDA UDI
- Generic Name
- Dental wedge, single-use FDA UDI
- Device Name
- Plastic Wedge, 16mm (L), Purple, Disposable FDA UDI
- Model / Reference
- WG-16 FDA UDI
- Description
- Plastic Wedge, 16mm (L), Purple, Disposable FDA UDI
Identifiers
- Catalog Number
- WG-16 FDA UDI
- Primary DI / UDI-DI
- D832WG161 FDA UDI
- FDA Product Code
- NRD FDA UDI
- GMDN Term
- Dental wedge, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 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
Acuwedge by Plasdent Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Bioclear Diamond Wedge — Bioclear Matrix Systems, LLC · Class I
- SoftWedge™ — GARRISON DENTAL SOLUTIONS, L.L.C. · Class I
- Wykle Wedges 17mm Green Color 500 count — WYKLE RESEARCH, INC. · Class I
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
- Plasdent Corp.
Sources (1)
- FDA UDI 3381acbd-907b-4ece-b8ad-19955ca6bd44 34 fields · synced May 30, 2026