Compact S S02
Compact S S02 is an ultrasonic dental scaling/debridement system (FDA Class II; FDA product code ELC, Scaler, Ultrasonic) made by Dmetec.Co., Ltd., cleared under FDA 510(k) K170104 on 27 Dec 2017 and listed in FDA GUDID since 19 Mar 2018 (UDI-DI 08809462190494), 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 | Number08809462190494 | Date19 Mar 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170104 | Date27 Dec 2017 | StatusActive |
Official records
- AccessGUDID record 08809462190494
- FDA 510(k) database K170104
Across registries
- FDA 510(k) K170104 decided 27 Dec 2017 Active
- FDA GUDID UDI-DI 08809462190494 listed 19 Mar 2018 Listed
Timeline
- Cleared FDA 510(k) K170104
- Listed FDA GUDID 08809462190494
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Compact S
- Generic name
- Ultrasonic dental scaling/debridement system
- Model / reference
- S02
- Primary DI / UDI-DI
- 08809462190494
- 510(k) Number
- FDA product code
- ELC
- GMDN term
- Ultrasonic dental scaling/debridement system
- Device class
- Class II
- Regulation number
- 872.4850
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Ultrasonic dental scaling/debridement system.