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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coating, Filling Material, Resin
510(k) Number K984037
Device Name CORE-IDE
Applicant
Roydent Dental Products, Inc.
1010 W. Hamlin Rd.
Rochester Hills,  MI  48309
Applicant Contact DONALD A LEROY
Correspondent
Roydent Dental Products, Inc.
1010 W. Hamlin Rd.
Rochester Hills,  MI  48309
Correspondent Contact DONALD A LEROY
Regulation Number872.3310
Classification Product Code
EBD  
Date Received11/12/1998
Decision Date 02/04/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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