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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 K990304
Device Name MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM
Applicant
Astra Tech, Inc.
430 Bedford St.
Suite 100
Lexington,  MA  02173
Applicant Contact NIKLAS LIDSKOG
Correspondent
Astra Tech, Inc.
430 Bedford St.
Suite 100
Lexington,  MA  02173
Correspondent Contact NIKLAS LIDSKOG
Regulation Number872.3640
Classification Product Code
DZE  
Date Received02/01/1999
Decision Date 07/15/1999
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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