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510(k) K990344

ORALGIENE TONGUE CLEANER by Oralgiene USA, Inc. — Product Code LCN

K990344 is an FDA 510(k) premarket notification submitted by Oralgiene USA, Inc. for the device "ORALGIENE TONGUE CLEANER". The FDA issued a decision of Substantially Equivalent on May 4, 1999. The device falls under product code LCN (Scraper, Tongue), a Class I device regulated under 21 CFR 872.6855.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 1999
Date Received
February 4, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scraper, Tongue
Device Class
Class I
Regulation Number
872.6855
Review Panel
DE
Submission Type

Other clearances for product code LCN

  • K992270 — MIRACLEBREATH TONGUE CLEANER (September 23, 1999)
  • K983683 — UNIK TONGUE CLEANER (January 14, 1999)
  • K983087 — BREATHTIQUE TONGUE SCRAPER (November 18, 1998)
  • K981808 — BREATHAID TONGUE SCRAPER (August 11, 1998)
  • K980842 — COPPER TONGUE SCRAPER (May 20, 1998)
  • K980075 — CYBERSONIC (March 4, 1998)
  • K973424 — ENFRESH TONGUE BRUSH (December 9, 1997)
  • K973175 — TONGUE KLEAN (October 14, 1997)
  • K972644 — BREATH-SO-FRESH TONGUE CLEANER (September 11, 1997)
  • K972131 — BREATH ACE BREATHFRESHENER (July 18, 1997)

FDA data resources