Cleared Traditional

K111828 - CLEARSPLINT ES

K111828 · Astron Dental Corporation · Dental device
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Oct 2011
Decision
120d
Days
-
Risk

K111828 is an FDA 510(k) clearance for the CLEARSPLINT ES. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Astron Dental Corporation (Lake Zurich, US). The FDA issued a Cleared decision on October 26, 2011 after a review of 120 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 - K111828

510(k) Number K111828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2011
Decision Date October 26, 2011
Days to Decision 120 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 128d · This submission: 120d
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 K111828.
DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX
K112868 · Dreamgard, Inc. · Jan 2012
SOMNOBRUX SPLINTS
K102909 · Somnomed, Inc. · Dec 2011
MIGRA TAB, QUICKSPLINT MIGRAINE
K111066 · Migratherapy, LLC · Nov 2011
FREEWAY COMFORT BITE GUARD
K110468 · Randmark Dental Products, LLC · Aug 2011
CLAYTON INTRA-AURAL DEVICE (CID)
K091880 · Ascentia Health Incorporated · Feb 2010
GRIND GUARD
K090472 · Archtek, Inc. · Oct 2009
K111828 · CLEARSPLINT ES
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