Cleared Traditional

K932997 - MICROPREP CAVITY PREPERATION SYSTEM

K932997 is an FDA 510(k) clearance for MICROPREP CAVITY PREPERATION SYSTEM, manufactured by Sunrise Technologies, Inc.. The device is a Class 2 Dental device with product code KOJ cleared through the Traditional 510(k) pathway after a 311-day FDA review.

K932997 · Sunrise Technologies, Inc. · Dental device
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Apr 1994
Decision
311d
Days
Class 2
Risk

K932997 is an FDA 510(k) clearance for the MICROPREP CAVITY PREPERATION SYSTEM. Classified as Airbrush (product code KOJ), Class II - Special Controls.

Submitted by Sunrise Technologies, Inc. (Fremont, US). The FDA issued a Cleared decision on April 25, 1994 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Sunrise Technologies, Inc. devices

FDA 510(k) Submission Details - K932997

510(k) Number K932997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1993
Decision Date April 25, 1994
Days to Decision 311 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 127d · This submission: 311d
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.