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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
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