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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 K952634
Device Name OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW
Applicant
Opti-Max
6281 Oak Bay Rd.
Port Ludlow,  WA  98365
Applicant Contact WILLIAM F ZINGHEIM
Correspondent
Opti-Max
6281 Oak Bay Rd.
Port Ludlow,  WA  98365
Correspondent Contact WILLIAM F ZINGHEIM
Regulation Number872.3640
Classification Product Code
DZE  
Date Received06/08/1995
Decision Date 09/18/1995
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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