Cleared Traditional

PRIMOSPLINT SYSTEM (K030832) - FDA 510(k) Clearance

K030832 · Cosmedent, Inc. · Dental device
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Sep 2003
Decision
184d
Days
-
Risk

K030832 is an FDA 510(k) clearance for the PRIMOSPLINT SYSTEM. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Cosmedent, Inc. (Chicago, US). The FDA issued a Cleared decision on September 17, 2003 after a review of 184 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 Cosmedent, Inc. devices

Submission Details

510(k) Number K030832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2003
Decision Date September 17, 2003
Days to Decision 184 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
57d slower than avg
Panel avg: 127d · This submission: 184d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -