ORALGIENE TONGUE CLEANER— 510(k) K990344

Substantially Equivalent

Oralgiene USA, Inc.

FDA 510(k) clearance K990344 for ORALGIENE TONGUE CLEANER, Substantially Equivalent on 1999-05-04. Applicant: Oralgiene USA, Inc.. Device class: 1.

Clearance details

Applicant: Oralgiene USA, Inc.
Product code: Code LCN
Device class: Class 1
Regulation: 21 CFR 872.6855
Advisory panel: Dental
Date received: 1999-02-04
Decision date: 1999-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCN

K992270 — MIRACLEBREATH TONGUE CLEANER1999-09-23
K983683 — UNIK TONGUE CLEANER1999-01-14
K983087 — BREATHTIQUE TONGUE SCRAPER1998-11-18
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.