Cleared Traditional

OCCLUSAL HARMONY IMPRESSION TRAY (K884316) - FDA 510(k) Clearance

Class I Dental device.

K884316 · Advantage Dental Co. · Dental device
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Dec 1988
Decision
70d
Days
Class 1
Risk

K884316 is an FDA 510(k) clearance for the OCCLUSAL HARMONY IMPRESSION TRAY. Classified as Tray, Impression, Preformed (product code EHY), Class I - General Controls.

Submitted by Advantage Dental Co. (Auburn Hills, US). The FDA issued a Cleared decision on December 22, 1988 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6880 - 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 Advantage Dental Co. devices

Submission Details

510(k) Number K884316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1988
Decision Date December 22, 1988
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 127d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EHY Tray, Impression, Preformed
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6880
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.