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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 K203000
Device Name KeyPrint KeySplint Hard
Applicant
Mycone Dental Supply Co. Inc. (Dba Keystone Industries)
480 S. Democrat Rd.
Gibbstown,  NJ  08027
Applicant Contact Diamond Bynum
Correspondent
Mycone Dental Supply Co. Inc. (Dba Keystone Industries)
480 S. Democrat Rd.
Gibbstown,  NJ  08027
Correspondent Contact Diamond Bynum
Classification Product Code
MQC  
Subsequent Product Codes
EBI   KMY  
Date Received10/01/2020
Decision Date 04/09/2021
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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