BREATHTIQUE TONGUE SCRAPER— 510(k) K983087

Name: FDA 510(k) clearance K983087
Creator: U.S. Food and Drug Administration
Published: 1998-11-18

Substantially Equivalent

Custom Medical Arts, Inc.

FDA 510(k) clearance K983087 for BREATHTIQUE TONGUE SCRAPER, Substantially Equivalent on 1998-11-18. Applicant: Custom Medical Arts, Inc.. Device class: 1.

Clearance details

Applicant: Custom Medical Arts, Inc.
Product code: Code LCN
Device class: Class 1
Regulation: 21 CFR 872.6855
Advisory panel: Dental
Date received: 1998-09-03
Decision date: 1998-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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
K981808 — BREATHAID TONGUE SCRAPER1998-08-11
K980842 — COPPER TONGUE SCRAPER1998-05-20

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