Cleared Traditional

OOLI-U(TONGUE SCRAPER) (K970042) - FDA 510(k) Clearance

Class I Dental device.

K970042 · Telefax Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
67d
Days
Class 1
Risk

K970042 is an FDA 510(k) clearance for the OOLI-U(TONGUE SCRAPER). Classified as Scraper, Tongue (product code LCN), Class I - General Controls.

Submitted by Telefax Intl. (Lake Forest, US). The FDA issued a Cleared decision on March 14, 1997 after a review of 67 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 Telefax Intl. devices

Submission Details

510(k) Number K970042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1997
Decision Date March 14, 1997
Days to Decision 67 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
60d faster than avg
Panel avg: 127d · This submission: 67d
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.