510(k) K080240
K080240 is an FDA 510(k) premarket notification submitted by Promident, LLC for the device "CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE". The FDA issued a decision of Substantially Equivalent on Feb 7, 2008. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Promident, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 7, 2008
- Date Received
- Jan 31, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Handpiece, Air-Powered, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type
- 510(k)