Cleared Traditional

K052513 - BABY SNOOPY WATER FILLED TEETHER, MODEL 95367

K052513 is an FDA 510(k) clearance for BABY SNOOPY WATER FILLED TEETHER, manufactured by Delta Enterprise Corporation. The device is a Class 2 Dental device with product code KKO cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K052513 · Delta Enterprise Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
287d
Days
Class 2
Risk

K052513 is an FDA 510(k) clearance for the BABY SNOOPY WATER FILLED TEETHER, MODEL 95367. Classified as Ring, Teething, Fluid-filled (product code KKO), Class II - Special Controls.

Submitted by Delta Enterprise Corporation (New York, US). The FDA issued a Cleared decision on June 28, 2006 after a review of 287 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 Delta Enterprise Corporation devices

FDA 510(k) Submission Details - K052513

510(k) Number K052513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2005
Decision Date June 28, 2006
Days to Decision 287 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 127d · This submission: 287d
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 K052513.
WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE
K110615 · Bebe Toys Manufactory , Ltd. · Dec 2011
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