The following data is part of a premarket notification filed by Sprintray Inc. with the FDA for Sprintray High Impact Denture Base.
| Device ID | K221678 |
| 510k Number | K221678 |
| Device Name: | SprintRay High Impact 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 | 2022-06-09 |
| Decision Date | 2022-11-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850039704229 | K221678 | 000 |
| 00850039704659 | K221678 | 000 |
| 00850039704666 | K221678 | 000 |
| 00850039704673 | K221678 | 000 |
| 00850039704680 | K221678 | 000 |
| 00850039704505 | K221678 | 000 |
| 10850039704182 | K221678 | 000 |
| 10850039704199 | K221678 | 000 |
| 10850039704205 | K221678 | 000 |
| 10850039704212 | K221678 | 000 |
| 10850039704403 | K221678 | 000 |