Cleared Traditional

K892264 - ORALCHEK SUPER-SOFT BRUSH

K892264 is an FDA 510(k) clearance for ORALCHEK SUPER-SOFT BRUSH, manufactured by Pfizer, Inc.. The device is a Class 1 Dental device with product code EFW cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K892264 · Pfizer, Inc. · Dental device
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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.

View all Pfizer, Inc. devices

FDA 510(k) Submission Details - K892264

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 -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 127d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

EFW Device Classification - Class 1, General Controls

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.

Regulatory Peers - EFW Toothbrush, Manual

All 12
Devices cleared under the same product code (EFW) and FDA review panel - the closest regulatory comparables to K892264.
BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH
K974761 · John O. Butler Co. · Jun 1998
CREST TOOTHBRUSH WITH MICROSHIELD
K973236 · Procter & Gamble Co. · Mar 1998
REACH ANTIBACTERIAL TOOTHBRUSH
K971589 · Personal Products Co. · Jul 1997
REACH* TOOTHBRUSH
K834580 · Johnson & Johnson Professionals, Inc. · Feb 1984
TOOTHBRUSH, REACH
K770749 · Johnson & Johnson Professionals, Inc. · Jun 1977
DENTAL STAIN REMOVER
K761352 · Concept, Inc. · Jan 1977