510(k) K130560
K130560 is an FDA 510(k) premarket notification submitted by Kaltenbach & Voigt GmbH for the device "MASTERTORQUE LUX 8900 L". The FDA issued a decision of Substantially Equivalent on September 27, 2013. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Kaltenbach & Voigt GmbH has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 2013
- Date Received
- March 4, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Air-Powered, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type