Cleared Traditional

MICODOSE CHLORHEXIPREP (K925163) - FDA 510(k) Clearance

Class I Dental device.

K925163 · Unicep · Dental device
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May 1993
Decision
226d
Days
Class 1
Risk

K925163 is an FDA 510(k) clearance for the MICODOSE CHLORHEXIPREP. Classified as Band, Preformed, Orthodontic (product code ECM), Class I - General Controls.

Submitted by Unicep (Sandpoint, US). The FDA issued a Cleared decision on May 27, 1993 after a review of 226 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 Unicep devices

Submission Details

510(k) Number K925163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1992
Decision Date May 27, 1993
Days to Decision 226 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 127d · This submission: 226d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ECM Band, Preformed, 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.