Sprintray, Inc.: FDA clearances and approvals
Sprintray, Inc. has 9 FDA 510(k) clearances (first 2021, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time: 99 days. Since 2017 its median was 99 days, against 126 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 99 |
| 2022 | 3 | 154 |
| 2023 | 1 | 143 |
| 2024 | 2 | 76 |
| 2025 | 1 | 60 |
| 2026 | 1 | 44 |
Review time against the same product codes
Since 2017, Sprintray, Inc.'s cleared 510(k)s took a median 99 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 4 | 4 |
| EBF | Material, Tooth Shade, Resin | 3 | 3 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| MQC | Mouthguard, Prescription | 1 | 1 |
Review panels
- Dental (9)
Most recent Sprintray, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260661 | Midas Restore | EBF | 2026-04-15 | 44 |
| K250617 | Apex Flex | EBI | 2025-04-29 | 60 |
| K242559 | Digital Temp | EBG | 2024-11-26 | 90 |
| K242277 | Crown HT | EBF | 2024-10-01 | 61 |
| K230445 | OnX Tough | EBI | 2023-07-14 | 143 |
| K222623 | Digital Crown | EBF | 2022-12-14 | 105 |
| K221678 | SprintRay High Impact Denture Base | EBI | 2022-11-10 | 154 |
| K220979 | SprintRay Denture Base | EBI | 2022-09-14 | 163 |
| K212448 | NightGuard Flex | MQC | 2021-11-12 | 99 |
Recalls
openFDA lists no recalls under a recalling firm named Sprintray, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Sprintray, Inc. have?
Sprintray, Inc. has 9 FDA 510(k) clearances (first 2021, latest 2026), across 4 product codes in 1 review panel.
How long does FDA take to clear Sprintray, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Sprintray, Inc.'s cleared 510(k)s is 99 days. Since 2017: 99 days, versus 126 days for all cleared 510(k)s in the same product codes.
What devices does Sprintray, Inc. make?
Its most frequent FDA product codes are EBI (Resin, Denture, Relining, Repairing, Rebasing, 4); EBF (Material, Tooth Shade, Resin, 3); EBG (Crown And Bridge, Temporary, Resin, 1).
Has Sprintray, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sprintray, Inc. Related entities may recall under other names.
Next steps
- See all 9 Sprintray, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBI, Sprintray, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.