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510(k) K961574

TONGUE SCRAPPER by U.S. Dentek Corp. — Product Code LCN

K961574 is an FDA 510(k) premarket notification submitted by U.S. Dentek Corp. for the device "TONGUE SCRAPPER". The FDA issued a decision of Substantially Equivalent on June 10, 1996. The device falls under product code LCN (Scraper, Tongue), a Class I device regulated under 21 CFR 872.6855. U.S. Dentek Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1996
Date Received
April 23, 1996
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 by U.S. Dentek Corp.

  • K931360 — ELECTRIC TOOTH-BRUSH (July 13, 1993)
  • K892861 — DENTAL PIK (September 15, 1989)
  • K881046 — SUPER PIK MASSAGING PICK FOR ORAL HYGIENE (May 13, 1988)

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)
  • K972644 — BREATH-SO-FRESH TONGUE CLEANER (September 11, 1997)

FDA data resources