Cleared Traditional

WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE (K110615) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

View all Bebe Toys Manufactory , Ltd. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 127d · This submission: 274d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.