CreoDent Solidex Customized Abutment

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.

Pre-market Notification Details

Device IDK202909
510k NumberK202909
Device Name:CreoDent Solidex Customized Abutment
ClassificationAbutment, Implant, Dental, Endosseous
Applicant CreoDent Prosthetics, Ltd. 29 West 30th Street, 11th Floor New York,  NY  10001
ContactCalvin Shim
CorrespondentChris Brown
Aclivi, LLC 6455 Farley Road Pinckney,  MI  48169
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-29
Decision Date2021-04-02

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