Cleared Abbreviated

K092025 - FLUID FILLED TEETHER - GEL

K092025 is an FDA 510(k) clearance for FLUID FILLED TEETHER - GEL, manufactured by Kids II. The device is a Class 2 Dental device with product code KKO cleared through the Abbreviated 510(k) pathway after a 570-day FDA review.

K092025 · Kids II · Dental device
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Jan 2011
Decision
570d
Days
Class 2
Risk

K092025 is an FDA 510(k) clearance for the FLUID FILLED TEETHER - GEL. Classified as Ring, Teething, Fluid-filled (product code KKO), Class II - Special Controls.

Submitted by Kids II (Alpharetta, US). The FDA issued a Cleared decision on January 27, 2011 after a review of 570 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5550 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

FDA 510(k) Submission Details - K092025

510(k) Number K092025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2009
Decision Date January 27, 2011
Days to Decision 570 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
442d slower than avg
Panel avg: 128d · This submission: 570d
Pathway characteristics
Standards-based clearance path.

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.

Regulatory Peers - KKO Ring, Teething, Fluid-filled

All 26
Devices cleared under the same product code (KKO) and FDA review panel - the closest regulatory comparables to K092025.
WATER-FILLED TEETHER
K123855 · Solid Toys Ind. , Ltd. · May 2013
WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE
K110615 · Bebe Toys Manufactory , Ltd. · Dec 2011
MAM COOLER
K093266 · Mam International AG · Jul 2010
MAM TWISTER
K092781 · Mam International AG · Jun 2010
GEL FILLED GUM SOOTHER
K092494 · Luv N' Care, Ltd. · Mar 2010
FU HONG INDUSTRIES LIMITED SOOTHER TEETHER
K093370 · Fu Hong Industries , Ltd. · Jan 2010
K092025 · FLUID FILLED TEETHER - GEL
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