Cleared Traditional

DENTAL AIR BRUSH (K780460) - FDA 510(k) Clearance

Class I Obstetrics & Gynecology device.

K780460 · M. Joel Gebhart, D.D.S. · Obstetrics & Gynecology device
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Jun 1978
Decision
98d
Days
Class 1
Risk

K780460 is an FDA 510(k) clearance for the DENTAL AIR BRUSH. Classified as Instrument, Manual, General Obstetric-gynecologic (product code KOH), Class I - General Controls.

Submitted by M. Joel Gebhart, D.D.S. (Mchenry, US). The FDA issued a Cleared decision on June 28, 1978 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4520 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all M. Joel Gebhart, D.D.S. devices

Submission Details

510(k) Number K780460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1978
Decision Date June 28, 1978
Days to Decision 98 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 160d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KOH Instrument, Manual, General Obstetric-gynecologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.4520
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.