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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 K926102
Device Name PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN
Applicant
Phoenix Dental, Inc.
11222 Wallaby Ct.
San Diego,  CA  92128
Applicant Contact ALAN DONALD
Correspondent
Phoenix Dental, Inc.
11222 Wallaby Ct.
San Diego,  CA  92128
Correspondent Contact ALAN DONALD
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/03/1992
Decision Date 06/22/1994
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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