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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, Orthodontic
510(k) Number K102769
Device Name NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE
Applicant
Jjgc Industria E Comercio DE Materiais Dentarios S
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Applicant Contact DAVID COLLETTE
Correspondent
Jjgc Industria E Comercio DE Materiais Dentarios S
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Correspondent Contact DAVID COLLETTE
Regulation Number872.3640
Classification Product Code
OAT  
Date Received09/24/2010
Decision Date 02/23/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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