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510(k) K002364

PROTEMP H by Espe Dental AG — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2000
Date Received
August 3, 2000
Clearance Type
Special
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 Espe Dental AG

  • K011394 — LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM (June 29, 2001)
  • K011154 — ELIPAR FREELIGHT (May 16, 2001)
  • K002793 — KETAC CEM U (September 26, 2000)
  • K001494 — MODIFICATION TO PROMPT L-POP (July 7, 2000)
  • K000595 — DIMENSION PENTA L (April 5, 2000)
  • K000591 — DIMENSION PENTA H, DIMENSION PENTA H QUICK (March 30, 2000)
  • K000588 — DIMENSION GARANT L, DIMENSION GARANT L QUICK (March 30, 2000)
  • K994192 — IMPREGUM PENTA M MONOSOFT (January 28, 2000)
  • K994193 — IMPREGUM PENTA DUOSOFT (January 28, 2000)
  • K994190 — IMPREGUM GARANT L DUOSOFT (January 27, 2000)

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)