CreoDent Solidex Customized Abutment And Screw

Abutment, Implant, Dental, Endosseous

CreoDent Prosthetics, Ltd.

The following data is part of a premarket notification filed by Creodent Prosthetics, Ltd. with the FDA for Creodent Solidex Customized Abutment And Screw.

Pre-market Notification Details

Device IDK202095
510k NumberK202095
Device Name:CreoDent Solidex Customized Abutment And Screw
ClassificationAbutment, Implant, Dental, Endosseous
Applicant CreoDent Prosthetics, Ltd. 29 West 30th Street, 11th Floor New York,  NY  10001
ContactCalvin Shim
CorrespondentCalvin Shim
CreoDent Prosthetics, Ltd. 29 West 30th Street, 11th Floor New York,  NY  10001
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-29
Decision Date2020-12-16

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