Cleared Traditional

DYNATORQ DENTAL HANDPIECE ATTACHMENTS (K896876) - FDA 510(k) Clearance

Class I Dental device.

K896876 · Micro Motors, Inc. · Dental device
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Mar 1990
Decision
89d
Days
Class 1
Risk

K896876 is an FDA 510(k) clearance for the DYNATORQ DENTAL HANDPIECE ATTACHMENTS. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Micro Motors, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on March 7, 1990 after a review of 89 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 Motors, Inc. devices

Submission Details

510(k) Number K896876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1989
Decision Date March 07, 1990
Days to Decision 89 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 127d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.