Cleared Traditional

K902974 - COOLING TEETHERS

K902974 is an FDA 510(k) clearance for COOLING TEETHERS, manufactured by Realgrow Intl. Corp.. The device is a Class 2 Dental device with product code KKO cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K902974 · Realgrow Intl. Corp. · Dental device
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Apr 1991
Decision
271d
Days
Class 2
Risk

K902974 is an FDA 510(k) clearance for the COOLING TEETHERS. Classified as Ring, Teething, Fluid-filled (product code KKO), Class II - Special Controls.

Submitted by Realgrow Intl. Corp. (San Dimas, US). The FDA issued a Cleared decision on April 3, 1991 after a review of 271 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5550 - 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 Realgrow Intl. Corp. devices

FDA 510(k) Submission Details - K902974

510(k) Number K902974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1990
Decision Date April 03, 1991
Days to Decision 271 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 127d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKO Device Classification - Class 2, Special Controls

Product Code KKO Ring, Teething, Fluid-filled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.