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510(k) K972644

BREATH-SO-FRESH TONGUE CLEANER by Intl. Dental Design Specialists, Inc. — Product Code LCN

K972644 is an FDA 510(k) premarket notification submitted by Intl. Dental Design Specialists, Inc. for the device "BREATH-SO-FRESH TONGUE CLEANER". The FDA issued a decision of Substantially Equivalent on September 11, 1997. 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
September 11, 1997
Date Received
July 15, 1997
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)
  • K990344 — ORALGIENE TONGUE CLEANER (May 4, 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)
  • K972131 — BREATH ACE BREATHFRESHENER (July 18, 1997)

FDA data resources