510(k) K854645

GOLD AIR, GOLD LIGHT by Alpine Dental Equipment Co. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1986
Date Received
November 19, 1985
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