NTI CLENCHING SUPPRESSION SYSTEM

Mouthguard, Prescription

HERAEUS KULZER, INC.

The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Nti Clenching Suppression System.

Pre-market Notification Details

Device IDK981546
510k NumberK981546
Device Name:NTI CLENCHING SUPPRESSION SYSTEM
ClassificationMouthguard, Prescription
Applicant HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend,  IN  46614 -2517
ContactCheryl V Zimmerman
CorrespondentCheryl V Zimmerman
HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend,  IN  46614 -2517
Product CodeMQC  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-30
Decision Date1998-07-15

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