510(k) K012308
K012308 is an FDA 510(k) premarket notification submitted by Kavo America for the device "KAVO QUATTROCARE". The FDA issued a decision of Substantially Equivalent on Jun 26, 2002. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Kavo America has 19 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 26, 2002
- Date Received
- Jul 23, 2001
- 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
- 510(k)