Cleared Traditional

K092494 - GEL FILLED GUM SOOTHER

K092494 is an FDA 510(k) clearance for GEL FILLED GUM SOOTHER, manufactured by Luv N' Care, Ltd.. The device is a Class 2 Dental device with product code KKO cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K092494 · Luv N' Care, Ltd. · Dental device
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Mar 2010
Decision
199d
Days
Class 2
Risk

K092494 is an FDA 510(k) clearance for the GEL FILLED GUM SOOTHER. Classified as Ring, Teething, Fluid-filled (product code KKO), Class II - Special Controls.

Submitted by Luv N' Care, Ltd. (Monroe, US). The FDA issued a Cleared decision on March 1, 2010 after a review of 199 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 Luv N' Care, Ltd. devices

FDA 510(k) Submission Details - K092494

510(k) Number K092494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2009
Decision Date March 01, 2010
Days to Decision 199 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
72d slower than avg
Panel avg: 127d · This submission: 199d
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.