Manufacturer registered with FDA
SprintRay Inc.
Huntington Beach, CA, United States. Lists 10 dental device types with FDA across 2 registered establishments, and holds 8 510(k) clearances as applicant.
- Device types listed
- 10
- Brands and models
- 39
- 510(k) clearances
- 82022–2026
- Markets registered in
- 979 registrations outside the US
- Establishments
- 2United States
510(k) clearances per year, 2007–2026
Registered in 9 markets
Where regulators' registries name SprintRay Inc. as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | SprintRay Inc. | 8 clearances | 2022–2026 | Below |
| European Union | EUDAMED | Manufacturer | Sprintray Inc. | 17 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SPRINTRAY INC. | 16 | 2024–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | SprintRay Inc. | 14 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | SPRINTRAY INC. | 13 | 2024–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | SprintRay Inc. | 11 | 2026–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Sprintray Inc.SprintRay Inc. | 4 | 2024–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Sprintray Inc | 3 | 2024–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | SprintRay Inc | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What SprintRay Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Apex Base (Light Pink, Original Pink, Dark Reddish Pink, Opaque Original Pink)Apex Flex - Light PinkApex Flex - Standard PinkCeramic Crown (Bleach, A1, A2, A3, B1, B3, C2, D2, D3)Crown HT (A1, A2, A3, B1, Unpigmented, Bleach)High Impact Denture Base (Light Pink, Original Pink, Dark Pink, Light Meharry, Original Meharry, Bubblegum)OnX Tough (Hollywood Bleach)OnX Tough 2 (Bleach, A1, A2, B1, Hollywood White)SprintRay Crown (Bleach, A1, A2, A3, B1, B3, C2, D2, D3)Standard Denture Base (Light Pink, Original Pink, Dark Pink, Light Meharry, Original Meharry, Dark Meharry) | 2022 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Ceramic Crown (Bleach, A1, A2, A3, B1, B3, C2, D2, D3)Crown HT (A1, A2, A3, B1, Unpigmented, Bleach)Midas Restore (A1, A2, A3, B1, Bleach, Unpigmented, C2)SprintRay Crown (Bleach, A1, A2, A3, B1, B3, C2, D2, D3) | 2022 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | Ceramic Crown (Bleach, A1, A2, A3, B1, B3, C2, D2, D3)Crown HT (A1, A2, A3, B1, Unpigmented, Bleach)Midas Restore (A1, A2, A3, B1, Bleach, Unpigmented, C2)SprintRay Crown (Bleach, A1, A2, A3, B1, B3, C2, D2, D3) | 2022 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | Apex Teeth (A1, A2, B1, Bleach)Crown HT (A1, A2, A3, B1, Unpigmented, Bleach)High Impact Denture Teeth (Bleach, A1, A2, A3, B1)NanoCeramic Hybrid OnX (Bleach, A1, B1)OnX Tough (Hollywood Bleach)OnX Tough 2 (Bleach, A1, A2, B1, Hollywood White)Standard Denture Teeth (A1, A2, A3, B1) | 2021 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | Crown HT (A1, A2, A3, B1, Unpigmented, Bleach)Digital Temp (A1, A2, B1, Bleach) | 2024 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Motto Day 1 Tray 1NightGuard FirmNightGuard Firm 2 (Midnight Purple)NightGuard FlexNightGuard Flex 2 (Simply Clear, Ocean Blue)SportsGuard (Clear, Crimson Red, Cobalt Blue) | 2021 |
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | Retainer (Clear, Natural, Black, Pink, Neon Green) | 2024 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Try-In 2 | 2019 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Precision GuideSurgical Guide 3 | 2019 |
| Indirect Bonding TrayQJJ · Class 1 | — | Maker | IDB 2IDB 3 | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names SprintRay Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 15 Apr 2026 | K260661 | Midas Restore | EBF Resin Tooth Shade Material |
| 29 Apr 2025 | K250617 | Apex Flex | EBI Rebasing Repairing Relining Denture Resin |
| 26 Nov 2024 | K242559 | Digital Temp | EBG Resin Temporary Crown and Bridge |
| 1 Oct 2024 | K242277 | Crown HT | EBF Resin Tooth Shade Material |
| 14 Jul 2023 | K230445 | OnX Tough | EBI Rebasing Repairing Relining Denture Resin |
| 14 Dec 2022 | K222623 | Digital Crown | EBF Resin Tooth Shade Material |
| 10 Nov 2022 | K221678 | SprintRay High Impact Denture Base | EBI Rebasing Repairing Relining Denture Resin |
| 14 Sep 2022 | K220979 | SprintRay Denture Base | EBI Rebasing Repairing Relining Denture Resin |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SPRINTRAY INC.FDA reg. 3014289665 | Los Angeles, CA, United States | Manufacturer |
| SPRINTRAY INC.FDA reg. 3024749697 | Huntington Beach, CA, United States | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10059580). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.