Cleared Abbreviated

K082824 - FLUID FILLED TEETHER

K082824 is an FDA 510(k) clearance for FLUID FILLED TEETHER, 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 244-day FDA review.

K082824 · Kids II · Dental device
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May 2009
Decision
244d
Days
Class 2
Risk

K082824 is an FDA 510(k) clearance for the FLUID FILLED TEETHER. 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 May 27, 2009 after a review of 244 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K082824

510(k) Number K082824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2008
Decision Date May 27, 2009
Days to Decision 244 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
116d slower than avg
Panel avg: 128d · This submission: 244d
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 K082824.
FLUID-FILLED TEETHER
K092910 · Qualiman Industrial Co., Ltd. · Dec 2009
LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING
K091198 · Allied Hill Enterprises, Ltd. · Dec 2009
PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER,
K090167 · Philips Electronics UK Limited · Jun 2009
FLUID-FILLED TEETHER
K083512 · Wiltec Industries , Ltd. · Apr 2009
GUMEASE DENTAL MOUTHPIECE
K072082 · Biomedevice , Ltd. · Nov 2007
BABY SNOOPY WATER FILLED TEETHER, MODEL 95367
K052513 · Delta Enterprise Corporation · Jun 2006
K082824 · FLUID FILLED TEETHER
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