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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 K954030
Device Name BONE-LOCK
Applicant
Leibinger GmbH
14540 Beltwood Pkwy. E.
Dallas,  TX  75244
Applicant Contact ANDREW B ROGERS
Correspondent
Leibinger GmbH
14540 Beltwood Pkwy. E.
Dallas,  TX  75244
Correspondent Contact ANDREW B ROGERS
Regulation Number872.3640
Classification Product Code
DZE  
Date Received08/28/1995
Decision Date 11/14/1997
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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