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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K172764
Device Name Keymill
Applicant
Mycone Dental Supply Company, Inc. (Aka Keystone Industries)
480 S. Democrat Rd.
Gibbstown,  NJ  08027
Applicant Contact Priscilla Herpai
Correspondent
Mycone Dental Supply Company, Inc. (Aka Keystone Industries)
480 S. Democrat Rd.
Gibbstown,  NJ  08027
Correspondent Contact Priscilla Herpai
Regulation Number872.3760
Classification Product Code
EBI  
Date Received09/13/2017
Decision Date 04/27/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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