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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 K170211
Device Name Insight Dental System
Applicant
Insight Dental System
4766 Research Dr.
San Antonio,  TX  78240
Applicant Contact Matthew Kaupp
Correspondent
Fdc Services
8708 Capehart Cove
Austin,  TX  78733
Correspondent Contact David Furr
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received01/24/2017
Decision Date 04/27/2017
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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