Cleared Traditional

K030292 - GROMAN PREPMASTER

K030292 is an FDA 510(k) clearance for GROMAN PREPMASTER, manufactured by Groman, Inc.. The device is a Class 2 Dental device with product code KOJ cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K030292 · Groman, Inc. · Dental device
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Apr 2003
Decision
77d
Days
Class 2
Risk

K030292 is an FDA 510(k) clearance for the GROMAN PREPMASTER. Classified as Airbrush (product code KOJ), Class II - Special Controls.

Submitted by Groman, Inc. (Margate, US). The FDA issued a Cleared decision on April 15, 2003 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6080 - 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 Groman, Inc. devices

FDA 510(k) Submission Details - K030292

510(k) Number K030292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2003
Decision Date April 15, 2003
Days to Decision 77 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 127d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOJ Device Classification - Class 2, Special Controls

Product Code KOJ Airbrush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6080
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KOJ Airbrush

All 28
Devices cleared under the same product code (KOJ) and FDA review panel - the closest regulatory comparables to K030292.
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DISPO ETCH
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DISPODRILL
K993124 · Kis Products · Aug 2001