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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K083670
Device Name UNIVERSAL, AESTHETICA, NATEA, NATURA
Applicant
Euroteknika
1100 Rene-Levesque-Blvd.
West -25th Floor
Montreal, Quebec,  CA H3B 5C9
Applicant Contact EMMANUEL MONTINI
Correspondent
Euroteknika
1100 Rene-Levesque-Blvd.
West -25th Floor
Montreal, Quebec,  CA H3B 5C9
Correspondent Contact EMMANUEL MONTINI
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/11/2008
Decision Date 07/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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