Cleared Traditional

K961574 - TONGUE SCRAPPER

K961574 is an FDA 510(k) clearance for TONGUE SCRAPPER, manufactured by U.S. Dentek Corp.. The device is a Class 1 Dental device with product code LCN cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K961574 · U.S. Dentek Corp. · Dental device
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Jun 1996
Decision
48d
Days
Class 1
Risk

K961574 is an FDA 510(k) clearance for the TONGUE SCRAPPER. Classified as Scraper, Tongue (product code LCN), Class I - General Controls.

Submitted by U.S. Dentek Corp. (Petaluma, US). The FDA issued a Cleared decision on June 10, 1996 after a review of 48 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 U.S. Dentek Corp. devices

FDA 510(k) Submission Details - K961574

510(k) Number K961574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1996
Decision Date June 10, 1996
Days to Decision 48 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
79d faster than avg
Panel avg: 127d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

LCN Device Classification - Class 1, General Controls

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.

Regulatory Peers - LCN Scraper, Tongue

All 18
Devices cleared under the same product code (LCN) and FDA review panel - the closest regulatory comparables to K961574.
AYURVEDIC TONGUE CLEANER
K971025 · Calello Martinez P.C. · May 1997
OOLI-U(TONGUE SCRAPER)
K970042 · Telefax Intl. · Mar 1997
OOLITT TONGUE CLEANER, REGULAR LOW RIPPLE/SPECIAL HIGH RIPPLE/LOW RIPPLE DOUBLE/HIGH & LOW RIPPLE/COMFORT EZE
K962941 · Deep Trading Corp. · Oct 1996
TONGUE CLEANER
K961660 · Jack Conrey · May 1996
COAT-A-COUNT PCP KIT NUMBER TKPC1
K870875 · Diagnostic Products Corp. · Mar 1987
MEDI-TECH DILATATION CATHETERS
K844292 · Medi-Tech, Inc. · Nov 1984