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510(k) K123849

NEW COMFORT-FIT DENTAL GUARD by Den Tek Oral Care, Inc. — Product Code OBR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2013
Date Received
December 14, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mouthguard, Over-The-Counter
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.

Other clearances by Den Tek Oral Care, Inc.

  • K151149 — Ready-Fit (September 30, 2015)
  • K130186 — DENTEK EASY BRUSH WITH FLUORIDE (July 15, 2013)
  • K091660 — CUSTOM COMFORT NIGHTGUARD VERSION 2 (June 12, 2009)
  • K083400 — CUSTOM COMFORT NIGHTGUARD (December 11, 2008)
  • K081669 — IMPROVED COMFORT-FIT NIGHTGUARD (July 10, 2008)
  • K072147 — DEN TEK COMFORT FIT NIGHTGUARD (August 30, 2007)
  • K063483 — DEN TEK NIGHTGUARD (January 23, 2007)

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