Filling Remover DTS
Ref 764-766EST
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number6438311RESTO102Y 06438311037646 | Date5 May 2022 | StatusActive |
| United States | GUDID listing GUDID | Number06438311037646 | Date31 Aug 2020 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Filling Remover DTS EUDAMEDLMDental GUDID
- Generic Name
- Dental restoration carver, resin
- Device Name
- Restorative dental hand instrument
- Model / Reference
- 764-766EST
- Primary DI / UDI-DI
- 06438311037646
- Basic UDI-DI
- 6438311RESTO102Y
- Direct Marketing DI
- 06438311037646
- FDA Product Code
- DZN
- EMDN Code
- Q01010199 Dental restoration devices - other
- GMDN Term
- Dental restoration carver, resin
- Device Class
- Class I
- Regulation Number
- 872.4565
- EU market of registration
- Finland
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Manufacturer details
- EUDAMED SRN
- FI-MF-000006705
Other devices from LM-Instruments Oy
Properties
Other properties (21)
- Sterile: No
- Single Use: No
- 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
- Serial Number: No
- Expiration Date: No