510(k) K894606

MICRO-AIRE HIGH SPEED DRILL (2910-000) by Micro-Aire Surgical Instruments, Inc. — Product Code EFB

K894606 is an FDA 510(k) premarket notification submitted by Micro-Aire Surgical Instruments, Inc. for the device "MICRO-AIRE HIGH SPEED DRILL (2910-000)". The FDA issued a decision of Substantially Equivalent on October 13, 1989. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Micro-Aire Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1989
Date Received
July 20, 1989
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