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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 K981002
Device Name ORION WX DENTAL ALLOY
Applicant
European Dental Imports, Inc.
49 Emerson Rd.
Durham,  NH  03824 -2112
Applicant Contact MICHAEL H EVERNGAM
Correspondent
European Dental Imports, Inc.
49 Emerson Rd.
Durham,  NH  03824 -2112
Correspondent Contact MICHAEL H EVERNGAM
Regulation Number872.3060
Classification Product Code
EJS  
Date Received03/18/1998
Decision Date 05/18/1998
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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