Cleared Traditional

DYNASONIC PLAQUE REMOVER & POLISHER DYNATIP (K903298) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K903298 · Micro Motors, Inc. · Dental device
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Apr 1991
Decision
266d
Days
Class 2
Risk

K903298 is an FDA 510(k) clearance for the DYNASONIC PLAQUE REMOVER & POLISHER DYNATIP. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Micro Motors, Inc. (Santa Ana, US). The FDA issued a Cleared decision on April 16, 1991 after a review of 266 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - 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. Standard predicate reliance. 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 Micro Motors, Inc. devices

Submission Details

510(k) Number K903298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1990
Decision Date April 16, 1991
Days to Decision 266 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 127d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
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 - ELC Scaler, Ultrasonic

All 36
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