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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 K924112
Device Name HYDROXYLAPATITE COATED SABER TECH SERIES I & SERIES II
Applicant
Saber Technology, Inc.
720 Olive Way
Suite 810
Seattle,  WA  98101
Applicant Contact STAN W SAPKOS
Correspondent
Saber Technology, Inc.
720 Olive Way
Suite 810
Seattle,  WA  98101
Correspondent Contact STAN W SAPKOS
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/24/1992
Decision Date 07/12/1994
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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