Implant Direct Sybron Manufacturing, LLC FDA Approvals

0 new drug approvals and 5 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Guided Surgery Kit510(k)Aug 16, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Aug 16, 2023
SMARTbase Abutment System510(k)Jun 20, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jun 20, 2023
Implant Direct Dental Implant Systems Portfolio - MR Conditional510(k)Feb 2, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Feb 2, 2023
Standard Sterilizable Tray510(k)Jan 28, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jan 28, 2021
Simply Iconic Implants510(k)Jan 22, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jan 22, 2021