Identity
- Trade Name
- Diamond Wedge Kit FDA UDI
- Generic Name
- Dental wedge, single-use FDA UDI
- Device Name
- Convenience kit of Bioclear products used in dental restorations. FDA UDI
- Model / Reference
- Original FDA UDI
- Description
- Convenience kit of Bioclear products used in dental restorations. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D9498120012 FDA UDI
- GMDN Term
- Dental wedge, single-use FDA UDI
Classification
- 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
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 Kit by Bioclear Matrix Systems, LLC — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Bioclear Matrix Systems, LLC
Sources (1)
- FDA UDI a8507c25-2c2f-4905-a679-9098b88553eb 33 fields · synced Jun 1, 2026