Cleared Traditional

K090167 - PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER,

K090167 is an FDA 510(k) clearance for PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, manufactured by Philips Electronics UK Limited. 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.

K090167 · Philips Electronics UK Limited · Dental device
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Jun 2009
Decision
147d
Days
Class 2
Risk

K090167 is an FDA 510(k) clearance for the PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHIL.... Classified as Ring, Teething, Fluid-filled (product code KKO), Class II - Special Controls.

Submitted by Philips Electronics UK Limited (Houston, US). The FDA issued a Cleared decision on June 18, 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.

View all Philips Electronics UK Limited devices

FDA 510(k) Submission Details - K090167

510(k) Number K090167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2009
Decision Date June 18, 2009
Days to Decision 147 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
20d slower than avg
Panel avg: 127d · 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.