510(k) K143704

Advanced Air System by W&H Dentalwerk Buermoos GmbH — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2015
Date Received
December 29, 2014
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