Data / Medical devices / United States / Sprintray Inc.
Sprintray Inc.: FDA-registered device maker in Huntington Beach, CA, United States, 9 510(k) clearances
Sprintray Inc. is registered with the FDA (registration 3024749697) in Huntington Beach, CA, United States. It lists 11 device types. The FDA files 9 510(k) clearances under its listings, the newest dated April 15, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3024749697
- Address
- 17601 Sampson Ln., Huntington Beach, CA, United States, 92647
- Owner or operator
- SprintRay Inc. (10059580)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 1, 2019
- Registered through
- 2027
- Brand names listed
- Apex Base (Light Pink, Original Pink, Dark Reddish Pink, Opaque Original Pink), Apex Flex - Light Pink, Apex Flex - Standard Pink, Apex Teeth (A1, A2, B1, Bleach), Ceramic Crown (Bleach, A1, A2, A3, B1, B3, C2, D2, D3), Crown HT (A1, A2, A3, B1, Unpigmented, Bleach), Digital Temp (A1, A2, B1, Bleach), High Impact Denture Base (Light Pink, Original Pink, Dark Pink, Light Meharry, Original Meharry, Bubblegum) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | 2 | Specification developer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Specification developer | accessdata.fda.gov |
| Denture, Plastic, Teeth | ELM | 2 | Specification developer | accessdata.fda.gov |
| Indirect Bonding Tray | QJJ | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Specification developer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Manufacturer, Specification developer | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Specification developer | accessdata.fda.gov |
| Retainer, Screw Expansion, Orthodontic | DYJ | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 15, 2026 | K260661 | Midas Restore | EBF | Substantially Equivalent | Sprintray, Inc. | accessdata.fda.gov |
| April 29, 2025 | K250617 | Apex Flex | EBI | Substantially Equivalent | Sprintray, Inc. | accessdata.fda.gov |
| November 26, 2024 | K242559 | Digital Temp | EBG | Substantially Equivalent | Sprintray, Inc. | accessdata.fda.gov |
| October 1, 2024 | K242277 | Crown HT | EBF | Substantially Equivalent | Sprintray, Inc. | accessdata.fda.gov |
| July 14, 2023 | K230445 | OnX Tough | EBI | Substantially Equivalent | Sprintray, Inc. | accessdata.fda.gov |
| December 14, 2022 | K222623 | Digital Crown | EBF | Substantially Equivalent | Sprintray, Inc. | accessdata.fda.gov |
| November 10, 2022 | K221678 | SprintRay High Impact Denture Base | EBI | Substantially Equivalent | Sprintray, Inc. | accessdata.fda.gov |
| September 14, 2022 | K220979 | SprintRay Denture Base | EBI | Substantially Equivalent | Sprintray, Inc. | accessdata.fda.gov |
| November 12, 2021 | K212448 | NightGuard Flex | MQC | Substantially Equivalent | Sprintray, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Additively Manufactured, Preformed, Resin Denture Tooth
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Retainer, Screw Expansion, Orthodontic
- All makers of Denture, Plastic, Teeth
- All makers of Material, Tooth Shade, Resin
- All makers of Material, Impression Tray, Resin
Updated April 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.