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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K830955
Device Name DENTAL CERAMIC FOR FABRICATION OF CROWN
Applicant
Dentsply Intl.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Dentsply Intl.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/25/1983
Decision Date 05/09/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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