Identity
- Trade Name
- Alpen Diamonds FDA UDI
- Generic Name
- Diamond dental bur, reusable FDA UDI
- Device Name
- Alpen Diamonds, G802 Round with Collar 012-02.3-M, FG, 5pcs FDA UDI
- Model / Reference
- 60031905 FDA UDI
- Description
- Alpen Diamonds, G802 Round with Collar 012-02.3-M, FG, 5pcs FDA UDI
Identifiers
- Catalog Number
- 60031905 FDA UDI
- Primary DI / UDI-DI
- 07630243613748 FDA UDI
- FDA Product Code
- DZP FDA UDI
- GMDN Term
- Diamond dental bur, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4535 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Diamond dental bur, reusable
Alpen Diamonds by Dent4You AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Diamond dental bur, reusable.
- Midwest Diamonds — Sirona Dental Systems GmbH · Class I
- Sabur by 3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
- Two Striper — ABRASIVE TECHNOLOGY, LLC · Class I
- Two Striper — ABRASIVE TECHNOLOGY, LLC · Class I
- MAXCUT DIAMOND BURS (6/pk) CRS 6852-012 — SCOTT'S DENTAL SUPPLY L.L.C. · Class I
- Two Striper — ABRASIVE TECHNOLOGY, LLC · Class I
- Diatech Diamond Instruments — Coltène/Whaledent AG · Class I
- HORICO — Hopf, Ringleb & Co. GmbH & Cie. · 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
- Dent4You AG
Sources (1)
- FDA UDI df45ba82-eac3-4ee5-957d-46c98b23f173 35 fields · synced May 31, 2026