Cleared Traditional

K972131 - BREATH ACE BREATHFRESHENER

K972131 is an FDA 510(k) clearance for BREATH ACE BREATHFRESHENER, manufactured by Beyond 21st Century, Inc.. The device is a Class 1 Dental device with product code LCN cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K972131 · Beyond 21st Century, Inc. · Dental device
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Jul 1997
Decision
42d
Days
Class 1
Risk

K972131 is an FDA 510(k) clearance for the BREATH ACE BREATHFRESHENER. Classified as Scraper, Tongue (product code LCN), Class I - General Controls.

Submitted by Beyond 21st Century, Inc. (Lenexa, US). The FDA issued a Cleared decision on July 18, 1997 after a review of 42 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 Beyond 21st Century, Inc. devices

FDA 510(k) Submission Details - K972131

510(k) Number K972131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1997
Decision Date July 18, 1997
Days to Decision 42 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
85d faster than avg
Panel avg: 127d · This submission: 42d
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 K972131.
ENFRESH TONGUE BRUSH
K973424 · Enfresh Products, LLC · Dec 1997
TONGUE KLEAN
K973175 · Softek Ent. · Oct 1997
BREATH-SO-FRESH TONGUE CLEANER
K972644 · Intl. Dental Design Specialists, Inc. · Sep 1997
BREATH TAKER
K971887 · Hofa, LLC · Jun 1997
AYURVEDIC TONGUE CLEANER
K971025 · Calello Martinez P.C. · May 1997
OOLI-U(TONGUE SCRAPER)
K970042 · Telefax Intl. · Mar 1997