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510(k) K253380

“FLNT Base” and “FLNT Temp” by Liaoning Upcera Co., Ltd. — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2026
Date Received
September 30, 2025
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 Liaoning Upcera Co., Ltd.

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  • K231687 — Gradual Dental Zirconia Blank (September 7, 2023)
  • K181167 — Upcera Glaze Paste, Glaze Powder, and Glaze Liquid (September 2, 2018)
  • K162323 — Tooth Shade Resin Material (January 12, 2017)
  • K152175 — Upcera Dental Zirconia Blank for Aesthetic Restoration (December 4, 2015)
  • K141727 — DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERI (December 18, 2014)
  • K141723 — UPCERA COLORING LIQUID (I AND II ) (October 22, 2014)
  • K141724 — UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK (October 22, 2014)

Other clearances for product code EBG

  • 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)
  • 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)
  • K223706 — PMMA BLOCK (May 12, 2023)