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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amalgamator, Dental, Ac-Powered
510(k) Number K914339
Device Name DENTOMAT 3 AMALGAMATORS
Applicant
Degussa AG
3950 S. Clinton Ave.
South Plainfield,  NJ  07080
Applicant Contact JOE RICHTER
Correspondent
Degussa AG
3950 S. Clinton Ave.
South Plainfield,  NJ  07080
Correspondent Contact JOE RICHTER
Regulation Number872.3100
Classification Product Code
EFD  
Date Received09/27/1991
Decision Date 11/07/1991
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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