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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 K033630
Device Name MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK
Applicant
Rhein 83 Srl
132 Monroe St.
Hoboken,  NJ  07030
Applicant Contact JOSEPH E GRASSO
Correspondent
Rhein 83 Srl
132 Monroe St.
Hoboken,  NJ  07030
Correspondent Contact JOSEPH E GRASSO
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/17/2003
Decision Date 04/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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