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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 K183598
Device Name KeyPrint KeySplint Soft
Applicant
Keystone Industries
480 S. Democrat Rd.
Gibbstown,  NJ  08027
Applicant Contact Negar Movahed
Correspondent
Keystone Industries
480 S. Democrat Rd.
Gibbstown,  NJ  08027
Correspondent Contact Negar Movahed
Classification Product Code
MQC  
Subsequent Product Code
KMY  
Date Received12/26/2018
Decision Date 11/15/2019
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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