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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 K851367
Device Name HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION
Applicant
Orthomatrix, Inc.
6968 Sierra Ct.
Dublin,  CA  94568
Applicant Contact THOMAS E CANE
Correspondent
Orthomatrix, Inc.
6968 Sierra Ct.
Dublin,  CA  94568
Correspondent Contact THOMAS E CANE
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/05/1985
Decision Date 05/21/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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