PRIMOSPLINT SYSTEM

Mouthguard, Prescription

COSMEDENT, INC.

The following data is part of a premarket notification filed by Cosmedent, Inc. with the FDA for Primosplint System.

Pre-market Notification Details

Device IDK030832
510k NumberK030832
Device Name:PRIMOSPLINT SYSTEM
ClassificationMouthguard, Prescription
Applicant COSMEDENT, INC. 401 NORTH MICHIGAN AVE. SUITE 2500 Chicago,  IL  60611
ContactMichael O'malley
CorrespondentMichael O'malley
COSMEDENT, INC. 401 NORTH MICHIGAN AVE. SUITE 2500 Chicago,  IL  60611
Product CodeMQC  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-17
Decision Date2003-09-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D831PSKIT1 K030832 000
D831PS204US0 K030832 000
D831PS202US0 K030832 000
D831PS100US1 K030832 000
EDEL13700300 K030832 000
EDEL13700200 K030832 000
EDEL13700100 K030832 000

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