Cleared Traditional

K083512 - FLUID-FILLED TEETHER

K083512 is an FDA 510(k) clearance for FLUID-FILLED TEETHER, manufactured by Wiltec Industries , Ltd.. The device is a Class 2 Dental device with product code KKO cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K083512 · Wiltec Industries , Ltd. · Dental device
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Apr 2009
Decision
147d
Days
Class 2
Risk

K083512 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 Wiltec Industries , Ltd. (Greenwood Village, US). The FDA issued a Cleared decision on April 22, 2009 after a review of 147 days - within the typical 510(k) review window.

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 - K083512

510(k) Number K083512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2008
Decision Date April 22, 2009
Days to Decision 147 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
19d slower than avg
Panel avg: 128d · This submission: 147d
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 K083512.
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
K082824 · Kids II · May 2009
GUMEASE DENTAL MOUTHPIECE
K072082 · Biomedevice , Ltd. · Nov 2007
BABY SNOOPY WATER FILLED TEETHER, MODEL 95367
K052513 · Delta Enterprise Corporation · Jun 2006
BERRY FRUITY TEETHER
K053493 · Evenflo Company, Inc. · Feb 2006
K083512 · FLUID-FILLED TEETHER
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