MDT Diamond Coated Dental Burs
by MDT Micro Diamond Technologies Ltd. Israel EUDAMEDGUDID
Ref HPC199020-01
Product code DZPEMDN Z12110102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number17291046761424 | Date12 May 2024 | StatusIn distribution |
| European Union | CE/MDR EUDAMED | Number7291046DiamondnonStrlRE | Date28 May 2023 | StatusActive |
Coverage
- Active
- 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
- HPC199020-01, HPC199020
- Primary DI / UDI-DI
- 17291046761424
- 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
- Market of Registration
- France
- Commercial Distribution
- 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 & raw data
Show properties, registry sources and raw records
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
Sources (2)
- EUDAMED 4997defc-b3f5-4a10-be0f-a5cf77ac7093
- FDA UDI e3810717-4124-4142-b503-a211e6c05d4b