Cleared Traditional

K002066 - FREEZER TEETHER

K002066 is an FDA 510(k) clearance for FREEZER TEETHER, manufactured by Cool Baby, Inc.. The device is a Class 2 Dental device with product code KKO cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K002066 · Cool Baby, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
81d
Days
Class 2
Risk

K002066 is an FDA 510(k) clearance for the FREEZER TEETHER. Classified as Ring, Teething, Fluid-filled (product code KKO), Class II - Special Controls.

Submitted by Cool Baby, Inc. (Edmond, US). The FDA issued a Cleared decision on September 26, 2000 after a review of 81 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cool Baby, Inc. devices

FDA 510(k) Submission Details - K002066

510(k) Number K002066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2000
Decision Date September 26, 2000
Days to Decision 81 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
46d faster than avg
Panel avg: 127d · This submission: 81d
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

Devices cleared under the same product code (KKO) and FDA review panel - the closest regulatory comparables to K002066.
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
GLOBAL TREASURES FLUID FILLED TEETHER
K043033 · Global Treasure Industries , Ltd. · Mar 2005
WATER FILLED GUM SOOTHER
K981202 · Corium Corp. · Jun 1998
SOOTHING WATER-FILLED TEETHER
K965082 · Consolidated Stores Corp. · Mar 1997
TYCO BABY SESAME STREET SOFT TEETHER
K963912 · Regu-Tech Assoc., Inc. · Nov 1996