Identity
- Trade Name
- ACE FDA UDI
- Generic Name
- Carbide dental bur, reusable FDA UDI
- Device Name
- BUR TAPER DOME #1703L, 44MM 2.1HD, 7CL STEP NOTCH 10/PKG FDA UDI
- Model / Reference
- 64441703ST FDA UDI
- Description
- BUR TAPER DOME #1703L, 44MM 2.1HD, 7CL STEP NOTCH 10/PKG FDA UDI
Identifiers
- Catalog Number
- 64441703ST FDA UDI
- Primary DI / UDI-DI
- 00614950012701 FDA UDI
- FDA Product Code
- EJL FDA UDI
- GMDN Term
- Carbide dental bur, reusable 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
No
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
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 2.1 Millimeter FDA UDI
Category: Carbide dental bur, reusable
Ace by Ace Surgical Supply Co., Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Alpen — Coltene/Whaledent Inc. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- Carbide burs — DFS - DIAMON GmbH · 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
- Ace Surgical Supply Co., Inc.
Sources (1)
- FDA UDI 39554d73-9708-420e-ba02-b509f0475a99 37 fields · synced Jun 6, 2026