510(k) K150798

Codent Low Speed Dental Handpieces and Accessories by Codent Technical Industry Co., Ltd. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2015
Date Received
March 26, 2015
Clearance Type
Special
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