Cleared Traditional

ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE) (K895854) - FDA 510(k) Clearance

Class I Dental device.

K895854 · Acme-Monaco Corp. · Dental device
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Apr 1990
Decision
188d
Days
Class 1
Risk

K895854 is an FDA 510(k) clearance for the ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE). Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Acme-Monaco Corp. (Plainville, US). The FDA issued a Cleared decision on April 9, 1990 after a review of 188 days - an extended review 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: 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 Acme-Monaco Corp. devices

Submission Details

510(k) Number K895854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1989
Decision Date April 09, 1990
Days to Decision 188 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 127d · This submission: 188d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EJF Bracket, Metal, 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.