The following data is part of a premarket notification filed by Sprintray Inc with the FDA for Sprintray Denture Base.
| Device ID | K220979 |
| 510k Number | K220979 |
| Device Name: | SprintRay Denture Base |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | SprintRay Inc 2705 Media Center Drive, Suite 100A Los Angeles, CA 90065 |
| Contact | Sara Moghtadernejad |
| Correspondent | Sara Moghtadernejad SprintRay Inc 2705 Media Center Drive, Suite 100A Los Angeles, CA 90065 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-04 |
| Decision Date | 2022-09-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850039704281 | K220979 | 000 |
| 10850039704250 | K220979 | 000 |
| 10850039704410 | K220979 | 000 |
| 10850039704274 | K220979 | 000 |
| 10850039704267 | K220979 | 000 |
| 10850039704243 | K220979 | 000 |
| 10850039704236 | K220979 | 000 |