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510(k) K972644

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

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

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  • 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)