| 510(k) Number |
K260661 |
| Device Name |
Midas Restore |
| Applicant |
| Sprintray, Inc. |
| 2710 Media Center Dr., Suite #100a |
|
Los Angeles,
CA
90065
|
|
| Applicant Contact |
Sara Moghtadernejad |
| Correspondent |
| Sprintray, Inc. |
| 2710 Media Center Dr., Suite #100a |
|
Los Angeles,
CA
90065
|
|
| Correspondent Contact |
Sara Moghtadernejad |
| Date Received | 03/02/2026 |
| Decision Date | 04/15/2026 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Dental
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|