Identity
- Trade Name
- EdgeBurs® FDA UDI
- Generic Name
- Carbide dental bur, single-use FDA UDI
- Device Name
- Operative Carbide Bur PR1-T COLOR BAND 10pk Orca Turbo Carbide Metal Cutting Bur PR1-T COLOUR FDA UDI
- Model / Reference
- PR1TCBND10 FDA UDI
- Description
- Operative Carbide Bur PR1-T COLOR BAND 10pk Orca Turbo Carbide Metal Cutting Bur PR1-T COLOUR FDA UDI
Identifiers
- Catalog Number
- PR1TCBND10 FDA UDI
- Primary DI / UDI-DI
- 00818365025336 FDA UDI
- FDA Product Code
- EJL FDA UDI
- GMDN Term
- Carbide dental bur, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3240 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Carbide dental bur, single-use
EdgeBurs® by US Endodontics, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carbide dental bur, single-use.
- MDT Diamond Coated Dental Burs — MDT Micro Diamond Technologies Ltd. · Class IIa
- SSW CARBIDE — SS White Burs LLC · Class I
- MDT Diamond Coated Dental Burs — MDT Micro Diamond Technologies Ltd. · Class IIa
- CYBERTECH — CB Healthcare Consulting GmbH · Class IIa
- SSW CARBIDE GREAT WHITE — SS White Burs LLC · Class I
- MDT Diamond Coated Dental Burs — MDT Micro Diamond Technologies Ltd. · Class IIa
- DIAMOND BUR 1015C - Box with 10 — 3R Indústria E Comércio LTDA · Class I
- MDT Diamond Coated Dental Burs — MDT Micro Diamond Technologies Ltd. · Class IIa
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
- US Endodontics, LLC
Sources (1)
- FDA UDI bcceccf5-3ec4-45bf-8ac8-033be50428a2 35 fields · synced Jun 1, 2026