Cleared Abbreviated

FLUID FILLED TEETHER - GEL (K092025) - FDA 510(k) Clearance

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K092025 · Kids II · Dental device
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Jan 2011
Decision
570d
Days
Class 2
Risk

K092025 is an FDA 510(k) clearance for the FLUID FILLED TEETHER - GEL. Classified as Ring, Teething, Fluid-filled (product code KKO), Class II - Special Controls.

Submitted by Kids II (Alpharetta, US). The FDA issued a Cleared decision on January 27, 2011 after a review of 570 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5550 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Kids II devices

Submission Details

510(k) Number K092025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2009
Decision Date January 27, 2011
Days to Decision 570 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
443d slower than avg
Panel avg: 127d · This submission: 570d
Pathway characteristics
Standards-based clearance path.

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.