510(k) Report

FDA applicant

Sprintray, Inc.

Los Angeles, CA9 decisions2021–20260 recalls

FDA records 9 decisions for Sprintray, Inc. (Los Angeles, CA) from 2021 to 2026: 9 510(k) clearances. Most are in product codes EBI (Resin, Denture, Relining, Repairing, Rebasing) and EBF (Material, Tooth Shade, Resin). Since 2016 its 510(k)s took a median of 102 days from receipt to decision, against 132 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Sprintray, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2021: 12022: 32023: 12024: 22025: 12026 (partial year): 1
2021high 3 (2022) · low 1 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Sprintray, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sprintray, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • EBIResin, Denture, Relining, Repairing, Rebasing4decisions
  • EBFMaterial, Tooth Shade, Resin2decisions
  • EBGCrown And Bridge, Temporary, Resin1decision
  • MQCMouthguard, Prescription1decision

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 102 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 132 days; 4 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K222623Digital CrownSprintray, Inc. · 20223cite it
  • K221678SprintRay High Impact Denture BaseSprintray, Inc. · 20223cite it
  • K250617Apex FlexSprintray, Inc. · 20253cite it
  • K230445OnX ToughSprintray, Inc. · 20232cite it
  • K242277Crown HTSprintray, Inc. · 20241cites it
  • K212448NightGuard FlexSprintray, Inc. · 20211cites it

What has FDA decided for it lately?

  • K260661Midas RestoreSprintray, Inc. · 2026
  • K250617Apex FlexSprintray, Inc. · 2025
  • K242559Digital TempSprintray, Inc. · 2024
  • K242277Crown HTSprintray, Inc. · 2024
  • K230445OnX ToughSprintray, Inc. · 2023
  • K222623Digital CrownSprintray, Inc. · 2022
  • K221678SprintRay High Impact Denture BaseSprintray, Inc. · 2022
  • K220979SprintRay Denture BaseSprintray, Inc. · 2022

All 9 as Sprintray, Inc. →