Cleared Traditional

A-COMPANY ELASTIC ROTATION WEDGES (K852597) - FDA 510(k) Clearance

Class I Dental device.

K852597 · A Company, Inc. · Dental device
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Jul 1985
Decision
42d
Days
Class 1
Risk

K852597 is an FDA 510(k) clearance for the A-COMPANY ELASTIC ROTATION WEDGES. Classified as Band, Elastic, Orthodontic (product code ECI), Class I - General Controls.

Submitted by A Company, Inc. (San Diego, US). The FDA issued a Cleared decision on July 31, 1985 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5410 - 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 A Company, Inc. devices

Submission Details

510(k) Number K852597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1985
Decision Date July 31, 1985
Days to Decision 42 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 127d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ECI Band, Elastic, Orthodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5410
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.