Cleared Traditional

SleepRight Select-Comfort Dental Guard (K212767) - FDA 510(k) Clearance

K212767 · Splintek, Inc. · Dental device
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Dec 2021
Decision
113d
Days
-
Risk

K212767 is an FDA 510(k) clearance for the SleepRight Select-Comfort Dental Guard. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Splintek, Inc. (Lenexa, US). The FDA issued a Cleared decision on December 22, 2021 after a review of 113 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 Splintek, Inc. devices

Submission Details

510(k) Number K212767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2021
Decision Date December 22, 2021
Days to Decision 113 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
14d faster than avg
Panel avg: 127d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 40
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