Identity
- Trade Name
- Burkhart Dental Supply FDA UDI
- Generic Name
- Dental wedge, single-use FDA UDI
- Device Name
- Matrix System Refill Small Wedges Blue(100) FDA UDI
- Model / Reference
- 72720969 FDA UDI
- Description
- Matrix System Refill Small Wedges Blue(100) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815878025549 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental wedge, single-use
Burkhart Dental Supply by Burkhart Dental Supply Co., The — 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
- Diamond Wedge — Bioclear Matrix Systems, LLC · Class I
- Bioclear Diamond Wedge — Bioclear Matrix Systems, LLC · Class I
- Bioclear Diamond Wedge — Bioclear Matrix Systems, LLC · Class I
- G-Wedge™ — GARRISON DENTAL SOLUTIONS, L.L.C. · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Burkhart Dental Supply Co., The
Sources (1)
- FDA UDI 5b695688-81c3-48c1-b446-3a236db7b26e 34 fields · synced Jun 8, 2026