510(k) K902402

HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE by Dentalez Group — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1990
Date Received
May 31, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type