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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Prescription
510(k) Number K981546
Device Name NTI CLENCHING SUPPRESSION SYSTEM
Applicant
HERAEUS KULZER, INC.
4315 SOUTH LAFAYETTE BLVD.
SOUTH BEND,  IN  46614 -2517
Applicant Contact CHERYL V ZIMMERMAN
Correspondent
HERAEUS KULZER, INC.
4315 SOUTH LAFAYETTE BLVD.
SOUTH BEND,  IN  46614 -2517
Correspondent Contact CHERYL V ZIMMERMAN
Classification Product Code
MQC  
Date Received04/30/1998
Decision Date 07/15/1998
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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