Identity
- Trade Name
- Diamond Wedge FDA UDI
- Generic Name
- Dental wedge, single-use FDA UDI
- Device Name
- Wedge used in dental restorations. FDA UDI
- Model / Reference
- Long Extra Large FDA UDI
- Description
- Wedge used in dental restorations. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D949112091501 FDA UDI
- FDA Product Code
- EJB 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
Diamond Wedge by Bioclear Matrix Systems, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental wedge, single-use.
- Henry Schein — HENRY SCHEIN, INC. · Class I
- G-Wedge™ — GARRISON DENTAL SOLUTIONS, L.L.C. · Class I
- SoftWedge™ — GARRISON DENTAL SOLUTIONS, L.L.C. · Class I
- Wykle Wedges 17mm Green Color 500 count — WYKLE RESEARCH, INC. · Class I
- Uni-Wedge Regular Orange (250) — Hager Worldwide, Inc. · Class I
- PRO-ELAST — Ortho Pro Dent LLC · Class I
- FenderMate — Directa AB · Class I
- SoftWedge™ — GARRISON DENTAL SOLUTIONS, L.L.C. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bioclear Matrix Systems, LLC
Sources (1)
- FDA UDI 32e899b9-9d3c-4634-9457-31c094446ed5 33 fields · synced May 30, 2026