BREATH-SO-FRESH TONGUE CLEANER— 510(k) K972644

Name: FDA 510(k) clearance K972644
Creator: U.S. Food and Drug Administration
Published: 1997-09-11

Substantially Equivalent

Intl. Dental Design Specialists, Inc.

FDA 510(k) clearance K972644 for BREATH-SO-FRESH TONGUE CLEANER, Substantially Equivalent on 1997-09-11. Applicant: Intl. Dental Design Specialists, Inc.. Device class: 1.

Clearance details

Applicant: Intl. Dental Design Specialists, Inc.
Product code: Code LCN
Device class: Class 1
Regulation: 21 CFR 872.6855
Advisory panel: Dental
Date received: 1997-07-15
Decision date: 1997-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Imperial Beach, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCN

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K992270 — MIRACLEBREATH TONGUE CLEANER1999-09-23
K990344 — ORALGIENE TONGUE CLEANER1999-05-04
K983683 — UNIK TONGUE CLEANER1999-01-14
K983087 — BREATHTIQUE TONGUE SCRAPER1998-11-18
K981808 — BREATHAID TONGUE SCRAPER1998-08-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.