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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Amalgam
510(k) Number K820389
Device Name A DENTAL AMALGAM ALLOY (UNNAMED
Applicant
Dentsply Intl.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Dentsply Intl.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.3070
Classification Product Code
EJJ  
Date Received02/10/1982
Decision Date 03/11/1982
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
Recalls CDRH Recalls
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