510(k) K935676

MICRO RSH HIGH SPEED HANDPIECE by Micro Motors, Inc. — Product Code EFB

K935676 is an FDA 510(k) premarket notification submitted by Micro Motors, Inc. for the device "MICRO RSH HIGH SPEED HANDPIECE". The FDA issued a decision of Substantially Equivalent on March 31, 1995. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Micro Motors, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1995
Date Received
November 26, 1993
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