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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 K131557
Device Name RITTER IMPLANT SYSTEM
Applicant
Ritter Implants GmbH CO KG
57 Lazy Brook Rd.
Monroe,  CT  06468
Applicant Contact RAYMOND KELLY
Correspondent
Ritter Implants GmbH CO KG
57 Lazy Brook Rd.
Monroe,  CT  06468
Correspondent Contact RAYMOND KELLY
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received05/29/2013
Decision Date 05/09/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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