Implant Misura MR3.4-5.8 DTS U
Ref 406-407ESTUModel Dental hand instrument for implant insertion
Withdrawn
CE MDD, withdrawn
Ended
Withdrawn
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-06438311214276 06438311214276 | Date8 Dec 2021 | StatusWithdrawn |
| United States | GUDID listing GUDID | Number06438311214276 | 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- Withdrawn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
- Implant Misura MR3.4-5.8 DTS U EUDAMEDLMDental GUDID
- Generic Name
- Manual dental burnisher, reusable
- Model / Reference
- Dental hand instrument for implant insertion, 406-407ESTU
- Primary DI / UDI-DI
- 06438311214276
- Basic UDI-DI
- B-06438311214276
- FDA Product Code
- DZN
- EMDN Code
- L159003 Dental and periodontal probes and explorers, reusable
- GMDN Term
- Manual dental burnisher, reusable
- Device Class
- Class I
- Regulation Number
- 872.4565
- EU market of registration
- Finland
- GUDID distribution status
- Not 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 (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