510(k) K973876
K973876 is an FDA 510(k) premarket notification submitted by Kavo America for the device "PROPHYFLEX 2, MODEL 2012". The FDA issued a decision of Substantially Equivalent on Dec 19, 1997. 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
- Dec 19, 1997
- Date Received
- Oct 10, 1997
- 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)