Cleared Traditional

K892264 - ORALCHEK SUPER-SOFT BRUSH (FDA 510(k) Clearance)

Class I Dental device.

K892264 · Pfizer, Inc. · Dental device
Jun 1989
Decision
70d
Days
Class 1
Risk

K892264 is an FDA 510(k) clearance for the ORALCHEK SUPER-SOFT BRUSH. Classified as Toothbrush, Manual (product code EFW), Class I - General Controls.

Submitted by Pfizer, Inc. (Ny, US). The FDA issued a Cleared decision on June 14, 1989 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6855 - 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.

Submission Details

510(k) Number K892264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1989
Decision Date June 14, 1989
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 158d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFW Toothbrush, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6855
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.