The following data is part of a premarket notification filed by Sdi Limited with the FDA for Stela Capsule System.
| Device ID | K222583 |
| 510k Number | K222583 |
| Device Name: | Stela Capsule System |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SDI Limited 3-15 Brunsdon Street, Bayswater Melbourne, AU 3153 |
| Contact | Quynh Jewell |
| Correspondent | Quynh Jewell SDI Limited 3-15 Brunsdon Street, Bayswater Melbourne, AU 3153 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-26 |
| Decision Date | 2022-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| DO3686400041 | K222583 | 000 |
| DO3686400031 | K222583 | 000 |