The following data is part of a premarket notification filed by Creodent Prosthetics, Ltd. with the FDA for Creodent Solidex Customized Abutment And Screw.
|Device Name:||CreoDent Solidex Customized Abutment And Screw|
|Classification||Abutment, Implant, Dental, Endosseous|
|Applicant||CreoDent Prosthetics, Ltd. 29 West 30th Street, 11th Floor New York, NY 10001|
CreoDent Prosthetics, Ltd. 29 West 30th Street, 11th Floor New York, NY 10001
|CFR Regulation Number||872.3630 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|