Cleared Traditional

K110615 - WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE

K110615 is an FDA 510(k) clearance for WATER FILLED TEETHER, manufactured by Bebe Toys Manufactory , Ltd.. The device is a Class 2 Dental device with product code KKO cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K110615 · Bebe Toys Manufactory , Ltd. · Dental device
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Dec 2011
Decision
274d
Days
Class 2
Risk

K110615 is an FDA 510(k) clearance for the WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE. Classified as Ring, Teething, Fluid-filled (product code KKO), Class II - Special Controls.

Submitted by Bebe Toys Manufactory , Ltd. (Stoughton, US). The FDA issued a Cleared decision on December 2, 2011 after a review of 274 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.

FDA 510(k) Submission Details - K110615

510(k) Number K110615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2011
Decision Date December 02, 2011
Days to Decision 274 days
Submission Type Traditional
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
146d slower than avg
Panel avg: 128d · This submission: 274d
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.

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 K110615.
WATER-FILLED TEETHER
K123855 · Solid Toys Ind. , Ltd. · May 2013
FLUID FILLED TEETHER - GEL
K092025 · Kids II · Jan 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
K110615 · WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE
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