Identity
- Trade Name
- Alpen Carbides FDA UDI
- Generic Name
- Carbide dental bur, reusable FDA UDI
- Device Name
- Alpen Carbides 6G-FG-1.80, 10 pcs FDA UDI
- Model / Reference
- R40006G FDA UDI
- Description
- Alpen Carbides 6G-FG-1.80, 10 pcs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630392905312 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
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Carbide dental bur, reusable
A comprehensive rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone, available in various shapes (e.g., cylinder, disk, sphere, oval), this is a reusable device.
Similar devices
Also classified as Carbide dental bur, reusable.
- EDENTA — EDENTA ETABLISSEMENT · Class I
- Alpen — Coltene/Whaledent Inc. · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Alpen — Coltene/Whaledent Inc. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Dent4You AG
Sources (1)
- FDA UDI 6d36bd82-22ec-406c-bc10-f80e458d9ce1 33 fields · synced Jul 24, 2026