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510(k) K243621

Evoblock, Perléon by Evoden Indústria Comércio Importação E Exportação — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2025
Date Received
November 22, 2024
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 for product code EBG

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  • 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)