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510(k) K061530

MD-TEMP by Meta Biomed Co., Ltd. — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2006
Date Received
June 2, 2006
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 Meta Biomed Co., Ltd.

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  • K230009 — EZ Bond Universal (March 3, 2023)
  • K210904 — Metapaste Plus (June 30, 2021)
  • K202617 — Metapex Plus (April 14, 2021)
  • K191991 — Ezfil (March 5, 2020)
  • K190724 — MD-Temp Plus (July 3, 2019)
  • K190503 — CeraSeal (June 7, 2019)
  • K190510 — GuttaSil (May 29, 2019)

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)
  • 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)