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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 K101225
Device Name PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1
Applicant
Promimic AB
Stena Center 1b
Goteborg,  SE SE-412 92
Applicant Contact KARIN BREDING
Correspondent
Promimic AB
Stena Center 1b
Goteborg,  SE SE-412 92
Correspondent Contact KARIN BREDING
Regulation Number872.3640
Classification Product Code
DZE  
Date Received05/03/2010
Decision Date 01/25/2011
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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