Cleared Traditional

DSG RELAXER SPLINT (K022627) - FDA 510(k) Clearance

K022627 · Sentage Corporation D/B/A/ Dental Services Group · Dental device
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Mar 2003
Decision
223d
Days
-
Risk

K022627 is an FDA 510(k) clearance for the DSG RELAXER SPLINT. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Sentage Corporation D/B/A/ Dental Services Group (Washington, US). The FDA issued a Cleared decision on March 18, 2003 after a review of 223 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.

View all Sentage Corporation D/B/A/ Dental Services Group devices

Submission Details

510(k) Number K022627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2002
Decision Date March 18, 2003
Days to Decision 223 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
96d slower than avg
Panel avg: 127d · This submission: 223d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -