Identity
- Trade Name
- Diatech Diamond Instruments FDA UDI
- Generic Name
- Diamond dental bur, reusable FDA UDI
- Model / Reference
- 211802DD FDA UDI
Identifiers
- Catalog Number
- MX59-010-10-C FDA UDI
- Primary DI / UDI-DI
- J006211802DD0 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Diamond dental bur, reusable
A high-performance rotary cutting device for the precise removal of hard structures in dentistry, including teeth and bone. Made from durable materials and available in various shapes.
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
- HORICO — Hopf, Ringleb & Co. GmbH & Cie. · Class I
- Sunshine Diamonds — Dr. Hopf GmbH & Co. KG · 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
- Coltène/Whaledent AG
Sources (1)
- FDA UDI 644e7e30-6379-4970-9b97-86aa0d4ddc27 34 fields · synced Jul 31, 2026