Home / 510(k) Clearances / K980075

510(k) K980075

CYBERSONIC by American Dentronics, Inc. — Product Code LCN

K980075 is an FDA 510(k) premarket notification submitted by American Dentronics, Inc. for the device "CYBERSONIC". The FDA issued a decision of Substantially Equivalent on March 4, 1998. The device falls under product code LCN (Scraper, Tongue), a Class I device regulated under 21 CFR 872.6855. American Dentronics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1998
Date Received
January 8, 1998
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 American Dentronics, Inc.

  • K935150 — SONIPLAK (May 18, 1994)
  • K935148 — SONIFLOSS (January 31, 1994)
  • K935149 — SONIBRUSH (January 31, 1994)

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)
  • 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