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510(k) K033022

PROTEMP 3 GARANT by 3M Espe AG Dental Products — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2003
Date Received
September 25, 2003
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 3M Espe AG Dental Products

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  • K094007 — UNICEM (April 8, 2010)
  • K093721 — COSP2 (February 19, 2010)
  • K091826 — ELEGANT (September 25, 2009)
  • K090718 — BELLUS SHADING KIT (September 21, 2009)
  • K080514 — PECD-01 AND PECD QUICK-01 (March 26, 2008)
  • K072055 — LAVA FRAME, LAVA FRAME SHADE (February 26, 2008)
  • K073296 — TEMPXN28 (January 9, 2008)
  • K071131 — UNO (July 25, 2007)

Other clearances for product code EBG

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  • 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)