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510(k) K072147

DEN TEK COMFORT FIT NIGHTGUARD by Den Tek Oral Care, Inc. — Product Code OBR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2007
Date Received
August 3, 2007
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)
  • K123849 — NEW COMFORT-FIT DENTAL GUARD (January 10, 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)
  • K063483 — DEN TEK NIGHTGUARD (January 23, 2007)

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  • K240810 — Anti Grinding Guard (May 24, 2024)
  • K232238 — Goyo Mouthpiece S (April 17, 2024)
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