510(k) K162926
K162926 is an FDA 510(k) premarket notification submitted by W&H Dentalwerk Burmoos GmbH for the device "Air-Powered Handpieces and Handpiece Attachments". The FDA issued a decision of Substantially Equivalent on Feb 23, 2017. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. W&H Dentalwerk Burmoos GmbH has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 23, 2017
- Date Received
- Oct 19, 2016
- 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)