Cleared Traditional

K030832 - PRIMOSPLINT SYSTEM

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

FDA 510(k) Submission Details - K030832

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 128d · This submission: 184d
Pathway characteristics
Predicate-based equivalence.

MQC Device Classification - Class 0,

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 67
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K030832.
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K053580 · Dental Concepts, LLC · Mar 2006
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ACCU-BITE HOME KIT DISCLUDER
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K981546 · Heraeus Kulzer, Inc. · Jul 1998