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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 K941619
Device Name LORENZ SURGICAL THREADED DENTAL IMPLANT
Applicant
Biomet, Inc.
Airport Industrial Park
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact PATRICIA SANDBORN BERES
Correspondent
Biomet, Inc.
Airport Industrial Park
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact PATRICIA SANDBORN BERES
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/04/1994
Decision Date 09/29/1994
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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