Cleared Traditional

K980995 - PLAQ-ATAQ-I

K980995 is an FDA 510(k) clearance for PLAQ-ATAQ-I, manufactured by Ethicare. The device is a Class 1 Dental device with product code EFW cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K980995 · Ethicare · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
174d
Days
Class 1
Risk

K980995 is an FDA 510(k) clearance for the PLAQ-ATAQ-I. Classified as Toothbrush, Manual (product code EFW), Class I - General Controls.

Submitted by Ethicare (Ft. Lauderdale, US). The FDA issued a Cleared decision on August 20, 1998 after a review of 174 days - an extended review 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: 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 Ethicare devices

FDA 510(k) Submission Details - K980995

510(k) Number K980995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1998
Decision Date August 20, 1998
Days to Decision 174 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
47d slower than avg
Panel avg: 127d · This submission: 174d
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 K980995.
LAZERSMILE, LAZERWHITE
K000290 · Biolase Technology, Inc. · Apr 2000
TOOTHBRUSH WASH
K994144 · Cal Huech, Inc. · Mar 2000
BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER
K992435 · Azo Enterprises · Oct 1999
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