510(k) K161488
K161488 is an FDA 510(k) premarket notification submitted by Kaltenbach & Voigt GmbH for the device "ESTETICA Dental Treatment Unit and Accessories". The FDA issued a decision of Substantially Equivalent on December 8, 2016. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Kaltenbach & Voigt GmbH has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 2016
- Date Received
- June 1, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Operative Dental
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type