Compact S, Compact S (LED)
510(k) K170104
Compact S, Compact S (LED) is a medical device (FDA Class II; FDA product code ELC, Scaler, Ultrasonic) made by Dmetec.Co., Ltd., cleared under FDA 510(k) K170104 on 27 Dec 2017, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK170104 | Date27 Dec 2017 | StatusActive |
Official records
- FDA 510(k) database K170104
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ELC
- Device class
- Class II
- Regulation
- 21 CFR Part 872.4850
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K170104
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| COMPACT S S02 | S02 | 08809462190494 | — | On the market |
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