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510(k) K231859

PrimmaArt by Dentscare Ltda — Product Code EBG

K231859 is an FDA 510(k) premarket notification submitted by Dentscare Ltda for the device "PrimmaArt". The FDA issued a decision of Substantially Equivalent on November 26, 2024. The device falls under product code EBG (Crown And Bridge, Temporary, Resin), a Class II device regulated under 21 CFR 872.3770. Dentscare Ltda has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2024
Date Received
June 23, 2023
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 Dentscare Ltda

  • K232994 — Vittra APS Unique Flow (October 18, 2024)
  • K210231 — Vittra APS Unique (October 14, 2021)
  • K201707 — Opallis, Opallis Flow (December 22, 2020)
  • K192682 — Orthocem, Ortho Bite (August 14, 2020)
  • K191389 — Allcem Veneer APS (February 25, 2020)
  • K191306 — Llis, Vittra APS (December 16, 2019)
  • K183424 — Ambar, Ambar APS, Ambar Universal APS (December 13, 2019)
  • K183465 — Allcem, Allcem Core (November 2, 2019)
  • K190758 — Opus Bulk Fill APS, Opus Bulk Fill Flow APS (September 4, 2019)

Other clearances for product code EBG

  • K261261 — Dura-Arch (April 17, 2026)
  • 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)
  • K242559 — Digital Temp (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)

FDA data resources