Cleared Traditional

K053580 - DOCTOR'S NIGHTGUARD

K053580 · Dental Concepts, LLC · Dental device
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Optimized for regulatory review, auditing and printing
Mar 2006
Decision
71d
Days
-
Risk

K053580 is an FDA 510(k) clearance for the DOCTOR'S NIGHTGUARD. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Dental Concepts, LLC (Washington, US). The FDA issued a Cleared decision on March 3, 2006 after a review of 71 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.

View all Dental Concepts, LLC devices

Submission Details

510(k) Number K053580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2005
Decision Date March 03, 2006
Days to Decision 71 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 127d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -