MDT Diamond Coated Dental Burs
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- MDT Diamond Coated Dental Burs EUDAMEDMDT Diamond Coated Dental Burs -Sterile FDA UDI
- Generic Name
- Diamond dental bur, single-use FDA UDI
- Device Name
- Sterile Diamond Coated Dental Burs EUDAMEDFG Rotary diamond instrument for dental application sterile FDA UDI
- Model / Reference
- 125012-36-61 EUDAMEDFDA UDI
- Description
- FG Rotary diamond instrument for dental application sterile FDA UDI
Identifiers
- Catalog Number
- 250-012SXC FDA UDI
- Primary DI / UDI-DI
- 67291046153859 EUDAMEDFDA UDI
- Basic UDI-DI
- 7291046DiamondSterileFM EUDAMED
- FDA Product Code
- DZP FDA UDI
- EMDN Code
- Q010501 DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE EUDAMED
- GMDN Term
- Diamond dental bur, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4535 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
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
Yes
Manufacturing Date
No
Category: Carbide dental bur, single-use
MDT Diamond Coated Dental Burs by MDT Micro Diamond Technologies Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Carbide dental bur, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7291046DiamondSterileFM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- MDT Micro Diamond Technologies Ltd.
- EUDAMED SRN
- IL-MF-000008464
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 2fb8307a-0a99-4874-bf00-a55efa5ea1ae 61 fields · synced Jun 8, 2026
- FDA UDI d86d6410-9b80-48d7-98ad-f1dec378d820 35 fields · synced May 30, 2026