Cleared Traditional

RELAX-O-GUARD (K925064) - FDA 510(k) Clearance

Class I Dental device.

K925064 · Aquatemp Service Co., Inc. · Dental device
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Sep 1993
Decision
342d
Days
Class 1
Risk

K925064 is an FDA 510(k) clearance for the RELAX-O-GUARD. Classified as Positioner, Tooth, Preformed (product code KMY), Class I - General Controls.

Submitted by Aquatemp Service Co., Inc. (Morristown, US). The FDA issued a Cleared decision on September 13, 1993 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5525 - 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. Elevated predicate reliance profile. 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 Aquatemp Service Co., Inc. devices

Submission Details

510(k) Number K925064 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 06, 1992
Decision Date September 13, 1993
Days to Decision 342 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
215d slower than avg
Panel avg: 127d · This submission: 342d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMY Positioner, Tooth, Preformed
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5525
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.