MDT Diamond Coated Dental Burs
by MDT Micro Diamond Technologies Ltd. 1,000+ variants
Ref 117018-34-45
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Overview
Explore the MDT Diamond Coated Dental Burs, a high-performance dental burs featuring non-sterile diamond coating, offering superior cutting efficiency and durability. This device is designed for general dentistry practitioners to efficiently remove soft tissue and shape bony structures in dental procedures.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number07291046287361 | Date12 May 2024 | StatusListed |
| European Union | CE/MDR EUDAMED | Number7291046DiamondnonStrlRE 07291046287361 | Date28 May 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Diamond dental bur, reusable
- Device Name
- Non-Sterile Diamond Coated Dental Burs
- Model / Ref / Catalog
- 117018-34-45, 170-018SM
- Primary DI / UDI-DI
- 07291046287361
- Basic UDI-DI
- 7291046DiamondnonStrlRE
- FDA Product Code
- DZP
- EMDN Code
- Z12110102 Dental drills
- GMDN Term
- Diamond dental bur, reusable
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 872.4535
- EU market of registration
- France
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class I |
Manufacturer details
- EUDAMED SRN
- IL-MF-000008464
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from MDT Micro Diamond Technologies Ltd.
Properties
Other properties (20)
- Sterile: No
- Single Use: No
- Implantable: 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
- Serial Number: No
- Expiration Date: No