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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 K925796
Device Name SPIRAL LOCK DENTAL IMPLANT SYSTEM
Applicant
Robert A James
11222 Wallaby Ct.
San Diego,  CA  92128
Applicant Contact ALAN DONALD
Correspondent
Robert A James
11222 Wallaby Ct.
San Diego,  CA  92128
Correspondent Contact ALAN DONALD
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/16/1992
Decision Date 05/23/1994
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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