Cleared Traditional

K963912 - TYCO BABY SESAME STREET SOFT TEETHER

K963912 is an FDA 510(k) clearance for TYCO BABY SESAME STREET SOFT TEETHER, manufactured by Regu-Tech Assoc., Inc.. The device is a Class 2 Dental device with product code KKO cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K963912 · Regu-Tech Assoc., Inc. · Dental device
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Nov 1996
Decision
37d
Days
Class 2
Risk

K963912 is an FDA 510(k) clearance for the TYCO BABY SESAME STREET SOFT TEETHER. Classified as Ring, Teething, Fluid-filled (product code KKO), Class II - Special Controls.

Submitted by Regu-Tech Assoc., Inc. (New York, US). The FDA issued a Cleared decision on November 6, 1996 after a review of 37 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 Regu-Tech Assoc., Inc. devices

FDA 510(k) Submission Details - K963912

510(k) Number K963912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1996
Decision Date November 06, 1996
Days to Decision 37 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
90d faster than avg
Panel avg: 127d · This submission: 37d
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.