Cleared Traditional

BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS (K013587) - FDA 510(k) Clearance

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

K013587 · Babies Best, Inc. · Dental device
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May 2002
Decision
196d
Days
Class 2
Risk

K013587 is an FDA 510(k) clearance for the BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS. Classified as Ring, Teething, Fluid-filled (product code KKO), Class II - Special Controls.

Submitted by Babies Best, Inc. (Vernon, US). The FDA issued a Cleared decision on May 14, 2002 after a review of 196 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 Babies Best, Inc. devices

Submission Details

510(k) Number K013587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2001
Decision Date May 14, 2002
Days to Decision 196 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
69d slower than avg
Panel avg: 127d · This submission: 196d
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.