510(k) K163414
K163414 is an FDA 510(k) premarket notification submitted by Nanning VV Dental Co., Ltd. for the device "Ultrasonic scaler". The FDA issued a decision of Substantially Equivalent on Nov 21, 2017. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 21, 2017
- Date Received
- Dec 5, 2016
- 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
- 510(k)