Cleared Traditional

CLEARSPLINT ES (K111828) - FDA 510(k) Clearance

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.

View all Astron Dental Corporation devices

Submission Details

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
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 127d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 70
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