510(k) K170104
K170104 is an FDA 510(k) premarket notification submitted by Dmetec.Co., Ltd. for the device "COMPACT S, COMPACT S (LED)". The FDA issued a decision of Substantially Equivalent on December 27, 2017. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Dmetec.Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 2017
- Date Received
- January 12, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scaler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 872.4850
- Review Panel
- DE
- Submission Type