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510(k) K142371

Luminesse PMMA by Talladium, Inc. — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2015
Date Received
August 25, 2014
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 Talladium, Inc.

  • K152023 — Luminesse Shaded Zirconia SZ (September 15, 2016)
  • K152066 — Luminesse Anterior Zirconia AT (October 21, 2015)
  • K143090 — LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID (June 15, 2015)
  • K140848 — LUMINESSE PORCELAIN SYSTEM (December 17, 2014)
  • K100232 — LUMINESSE ZR BLANKS (May 21, 2010)
  • K894085 — TALLADIUM TILITE CERAMIC ALLOY (December 20, 1989)

Other clearances for product code EBG

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  • 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)
  • 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)