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510(k) K251271

TempFIT Temporary Crown and Bridge Resin by Rizhao Huge Biomaterials Company, Ltd. — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2025
Date Received
April 24, 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

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Other clearances for product code EBG

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  • 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)