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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K080146
Device Name ZIRKONDENT
Applicant
Ergometa
144 Los Flores
Aliso Viejo,  CA  92656
Applicant Contact MIKE ARTEMOV
Correspondent
Ergometa
144 Los Flores
Aliso Viejo,  CA  92656
Correspondent Contact MIKE ARTEMOV
Regulation Number872.6660
Classification Product Code
EIH  
Date Received01/22/2008
Decision Date 06/06/2008
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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