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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 K882578
Device Name ASTRA DENTAL IMPLANT SYSTEM
Applicant
Astra Meditec AB
P.O. Box 14
S-4321 21 Molndal
Sweden,  SE
Applicant Contact ANDERS HOLMEN
Correspondent
Astra Meditec AB
P.O. Box 14
S-4321 21 Molndal
Sweden,  SE
Correspondent Contact ANDERS HOLMEN
Regulation Number872.3640
Classification Product Code
DZE  
Date Received06/22/1988
Decision Date 08/12/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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