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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 K901927
Device Name HA-TI (HAND-TITANIUM SCREW) IMPLANT
Applicant
Mathys Corp. of North America
7 Great Valley Pkwy.
Suite 223
Malvern,  PA  19355
Applicant Contact HEINZ E WICK
Correspondent
Mathys Corp. of North America
7 Great Valley Pkwy.
Suite 223
Malvern,  PA  19355
Correspondent Contact HEINZ E WICK
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/30/1990
Decision Date 01/04/1991
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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