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510(k) K242559

Digital Temp by Sprintray, Inc. — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2024
Date Received
August 28, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Crown And Bridge, Temporary, Resin
Device Class
Class II
Regulation Number
872.3770
Review Panel
DE
Submission Type

Other clearances by Sprintray, Inc.

  • K250617 — Apex Flex (April 29, 2025)
  • K242277 — Crown HT (October 1, 2024)
  • K230445 — OnX Tough (July 14, 2023)
  • K222623 — Digital Crown (December 14, 2022)
  • K221678 — SprintRay High Impact Denture Base (November 10, 2022)
  • K220979 — SprintRay Denture Base (September 14, 2022)
  • K212448 — NightGuard Flex (November 12, 2021)

Other clearances for product code EBG

  • K253380 — “FLNT Base” and “FLNT Temp” (March 2, 2026)
  • K251271 — TempFIT Temporary Crown and Bridge Resin (June 23, 2025)
  • K243370 — DentaTOOTH (May 5, 2025)
  • K243621 — Evoblock, Perléon (April 22, 2025)
  • K243951 — TEMP MASTER, PMMA-based dental resin (February 21, 2025)
  • K231859 — PrimmaArt (November 26, 2024)
  • K240538 — Premium Teeth Resin (July 19, 2024)
  • K241226 — Fixtemp® C&B 4:1 (May 31, 2024)
  • K233868 — dima Print Teeth & Temp (May 23, 2024)
  • K223706 — PMMA BLOCK (May 12, 2023)