Cleared Traditional

K112868 - DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX

K112868 · Dreamgard, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
111d
Days
-
Risk

K112868 is an FDA 510(k) clearance for the DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Dreamgard, Inc. (Washington, US). The FDA issued a Cleared decision on January 19, 2012 after a review of 111 days - within the typical 510(k) review window.

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 - K112868

510(k) Number K112868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2011
Decision Date January 19, 2012
Days to Decision 111 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
17d faster than avg
Panel avg: 128d · This submission: 111d
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 K112868.
M-PM-DISC
K134015 · Merz Dental GmbH · Apr 2014
SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE
K123161 · Smartguard, Inc. · Mar 2013
THERMOFORMED MOUTHGUARDS
K121365 · Glidewell Laboratories-Sleep Devices Group · Nov 2012
SOMNOBRUX SPLINTS
K102909 · Somnomed, Inc. · Dec 2011
MIGRA TAB, QUICKSPLINT MIGRAINE
K111066 · Migratherapy, LLC · Nov 2011
CLEARSPLINT ES
K111828 · Astron Dental Corporation · Oct 2011
K112868 · DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX
Download PDF FDA Summary Dreamgard, Inc.