Cleared Traditional

K850597 - MICRO-AIRE HIGH SPEED ORAL SURGERG DRILL

K850597 is an FDA 510(k) clearance for MICRO-AIRE HIGH SPEED ORAL SURGERG DRILL, manufactured by Micro-Aire Surgical Instruments, Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K850597 · Micro-Aire Surgical Instruments, Inc. · Dental device
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Mar 1985
Decision
38d
Days
Class 1
Risk

K850597 is an FDA 510(k) clearance for the MICRO-AIRE HIGH SPEED ORAL SURGERG DRILL. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Micro-Aire Surgical Instruments, Inc. (San Fernando, US). The FDA issued a Cleared decision on March 25, 1985 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Micro-Aire Surgical Instruments, Inc. devices

FDA 510(k) Submission Details - K850597

510(k) Number K850597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1985
Decision Date March 25, 1985
Days to Decision 38 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 127d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.