Cleared Traditional

K063483 - DEN TEK NIGHTGUARD

K063483 · Den Tek Oral Care, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
67d
Days
-
Risk

K063483 is an FDA 510(k) clearance for the DEN TEK NIGHTGUARD. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Den Tek Oral Care, Inc. (Washington, US). The FDA issued a Cleared decision on January 23, 2007 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K063483

510(k) Number K063483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2006
Decision Date January 23, 2007
Days to Decision 67 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 128d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

MQC Device Classification - Class 0,

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 71
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K063483.
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K063483 · DEN TEK NIGHTGUARD
Download PDF FDA Summary Den Tek Oral Care, In…