Cleared Traditional

K994144 - TOOTHBRUSH WASH

K994144 is an FDA 510(k) clearance for TOOTHBRUSH WASH, manufactured by Cal Huech, Inc.. The device is a Class 1 Dental device with product code EFW cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K994144 · Cal Huech, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
86d
Days
Class 1
Risk

K994144 is an FDA 510(k) clearance for the TOOTHBRUSH WASH. Classified as Toothbrush, Manual (product code EFW), Class I - General Controls.

Submitted by Cal Huech, Inc. (Warner Robins, US). The FDA issued a Cleared decision on March 2, 2000 after a review of 86 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 Cal Huech, Inc. devices

FDA 510(k) Submission Details - K994144

510(k) Number K994144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1999
Decision Date March 02, 2000
Days to Decision 86 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 127d · This submission: 86d
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 10
Devices cleared under the same product code (EFW) and FDA review panel - the closest regulatory comparables to K994144.
LAZERSMILE, LAZERWHITE
K000290 · Biolase Technology, Inc. · Apr 2000
BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER
K992435 · Azo Enterprises · Oct 1999
PLAQ-ATAQ-I
K980995 · Ethicare · Aug 1998
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