Deka Smartperio M128A1
by El.en. SpA
Deka Smartperio M128A1 is a Class II device made by El.en. SpA, cleared under FDA 510(k) K213658 on 11 Mar 2022 (1 earlier submission) and listed in FDA GUDID since 5 Apr 2022 (UDI-DI 08057017760528), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08057017760528 | Date5 Apr 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213658 | Date11 Mar 2022 | StatusActive |
Official records
- AccessGUDID record 08057017760528
- FDA 510(k) database K213658
- FDA 510(k) database K203396
Across registries
- FDA 510(k) K213658 decided 11 Mar 2022 Active
- FDA GUDID UDI-DI 08057017760528 listed 5 Apr 2022 Listed
Timeline
- Cleared FDA 510(k) K203396
- Cleared FDA 510(k) K213658
- Listed FDA GUDID 08057017760528
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Deka Smartperio
- Generic name
- Dental solid-state laser system
- Model / Ref / Catalog
- M128A1
- Primary DI / UDI-DI
- 08057017760528
- FDA product code
- GEX, NVK
- GMDN term
- Dental solid-state laser system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Dental solid-state laser system.