Cleared Traditional

K121365 - THERMOFORMED MOUTHGUARDS

K121365 · Glidewell Laboratories-Sleep Devices Group · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
197d
Days
-
Risk

K121365 is an FDA 510(k) clearance for the THERMOFORMED MOUTHGUARDS. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Glidewell Laboratories-Sleep Devices Group (Irvine, US). The FDA issued a Cleared decision on November 20, 2012 after a review of 197 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K121365

510(k) Number K121365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2012
Decision Date November 20, 2012
Days to Decision 197 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
69d slower than avg
Panel avg: 128d · This submission: 197d
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 K121365.
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K123161 · Smartguard, Inc. · Mar 2013
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K112868 · Dreamgard, Inc. · Jan 2012
SOMNOBRUX SPLINTS
K102909 · Somnomed, Inc. · Dec 2011
MIGRA TAB, QUICKSPLINT MIGRAINE
K111066 · Migratherapy, LLC · Nov 2011
K121365 · THERMOFORMED MOUTHGUARDS
Download PDF FDA Summary Glidewell Laboratorie…