The following data is part of a premarket notification filed by Sdi Limited with the FDA for Stela Capsule System.
|Device Name:||Stela Capsule System|
|Classification||Material, Tooth Shade, Resin|
|Applicant||SDI Limited 3-15 Brunsdon Street, Bayswater Melbourne, AU 3153|
SDI Limited 3-15 Brunsdon Street, Bayswater Melbourne, AU 3153
|CFR Regulation Number||872.3690 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|