Cleared Traditional

K053580 - DOCTOR'S NIGHTGUARD

K053580 · Dental Concepts, LLC · Dental device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K053580

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 127d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

MQC Device Classification - Class 0,

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 62
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K053580.
NIGHT GUARD
K061122 · Alpine Oral Care, LLC · Mar 2007
DEN TEK NIGHTGUARD
K063483 · Den Tek Oral Care, Inc. · Jan 2007
MOUTHGUARD AND ALIGNER MATERIALS
K062828 · Dentsply Intl., Inc. · Nov 2006
PRIMOSPLINT SYSTEM
K030832 · Cosmedent, Inc. · Sep 2003
ACCU-BITE HOME KIT DISCLUDER
K980953 · Jerome M. Simon · Oct 1998
NTI CLENCHING SUPPRESSION SYSTEM
K981546 · Heraeus Kulzer, Inc. · Jul 1998