FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

MICRO-AIRE HIGH SPEED DRILL (2910-000)

K Number: K894606 · Decision Oct 13, 1989
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
260
Applicant Total
40
Review Days
85

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Basic Information

Device Name
MICRO-AIRE HIGH SPEED DRILL (2910-000)
K Number
K894606
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
872.4200
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Micro-Aire Surgical Instruments, Inc.
Date Received
July 20, 1989
Decision Date
October 13, 1989
Product Code
EFB
Advisory Committee
Dental
Review Advisory Committee
DE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
EFB Handpiece, Air-Powered, Dental

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Other Clearances by Micro-Aire Surgical Instruments, Inc.

K Number Device Name
K904949 A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS
K903713 OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229
K902676 MICROGUARD, ORTHOPEDIC PIN PROTECTORS
K903650 OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305
K903664 MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL
K901967 DENDIA WERK BURS AND CUTTING DISCS
K901735 ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444
K902168 ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS)
K900033 MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS
K900210 BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500
Search all 40 clearances from Micro-Aire Surgical Instruments, Inc. →