LM-Syntette DTS
by LM-Instruments Oy EUDAMEDGUDID
Active
Ref 215-216ESTModel Dental hand instrument, curette for the removal of the subgingival and supragingival calculus
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-06438311011523 | Date8 Dec 2021 | StatusActive |
| United States | GUDID listing GUDID | Number06438311011523 | Date31 Aug 2020 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls on record, checked 25 Oct 2026.
Specification
- Trade Name
- LM-Syntette DTS EUDAMEDLMDental GUDID
- Generic Name
- Periodontal curette
- Device Name
- Periodontal hand instrument
- Model / Reference
- Dental hand instrument, curette for the removal of the subgingival and supragingival calculus, 215-216EST
- Primary DI / UDI-DI
- 06438311011523
- Basic UDI-DI
- B-06438311011523, 6438311PERIO1r06S
- Direct Marketing DI
- 06438311011523
- FDA Product Code
- DZN
- EMDN Code
- L159001 Dental and periodontal curettes, reusable
- GMDN Term
- Periodontal curette
- Device Class
- Class I
- Regulation Number
- 872.4565
- 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 (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