Cleared Traditional

ENFRESH TONGUE BRUSH (K973424) - FDA 510(k) Clearance

Class I Dental device.

K973424 · Enfresh Products, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
90d
Days
Class 1
Risk

K973424 is an FDA 510(k) clearance for the ENFRESH TONGUE BRUSH. Classified as Scraper, Tongue (product code LCN), Class I - General Controls.

Submitted by Enfresh Products, LLC (Washington, US). The FDA issued a Cleared decision on December 9, 1997 after a review of 90 days - within the typical 510(k) review window.

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 Enfresh Products, LLC devices

Submission Details

510(k) Number K973424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1997
Decision Date December 09, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCN Scraper, Tongue
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.