Cleared Traditional

K971025 - AYURVEDIC TONGUE CLEANER

K971025 is an FDA 510(k) clearance for AYURVEDIC TONGUE CLEANER, manufactured by Calello Martinez P.C.. The device is a Class 1 Dental device with product code LCN cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K971025 · Calello Martinez P.C. · Dental device
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May 1997
Decision
63d
Days
Class 1
Risk

K971025 is an FDA 510(k) clearance for the AYURVEDIC TONGUE CLEANER. Classified as Scraper, Tongue (product code LCN), Class I - General Controls.

Submitted by Calello Martinez P.C. (Nutley, US). The FDA issued a Cleared decision on May 22, 1997 after a review of 63 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 Calello Martinez P.C. devices

FDA 510(k) Submission Details - K971025

510(k) Number K971025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1997
Decision Date May 22, 1997
Days to Decision 63 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
64d faster than avg
Panel avg: 127d · This submission: 63d
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 8
Devices cleared under the same product code (LCN) and FDA review panel - the closest regulatory comparables to K971025.
BREATH-SO-FRESH TONGUE CLEANER
K972644 · Intl. Dental Design Specialists, Inc. · Sep 1997
BREATH ACE BREATHFRESHENER
K972131 · Beyond 21st Century, Inc. · Jul 1997
BREATH TAKER
K971887 · Hofa, LLC · Jun 1997
OOLI-U(TONGUE SCRAPER)
K970042 · Telefax Intl. · Mar 1997
COAT-A-COUNT PCP KIT NUMBER TKPC1
K870875 · Diagnostic Products Corp. · Mar 1987
MEDI-TECH DILATATION CATHETERS
K844292 · Medi-Tech, Inc. · Nov 1984