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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Carver, Dental Amalgam, Operative
510(k) Number K821785
Device Name BEACH AMALGAM CARVER
Applicant
Pacific Dental Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Pacific Dental Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.4565
Classification Product Code
EKH  
Date Received06/17/1982
Decision Date 07/06/1982
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
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