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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Other Noble Metal
510(k) Number K980661
Device Name CERA E DENTAL ALLOY
Applicant
European Dental Imports, Inc.
49 Emerson Rd.
Durham,  NH  03824
Applicant Contact GISELA N EVERNGAM
Correspondent
European Dental Imports, Inc.
49 Emerson Rd.
Durham,  NH  03824
Correspondent Contact GISELA N EVERNGAM
Regulation Number872.3060
Classification Product Code
EJS  
Date Received02/20/1998
Decision Date 05/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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