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510(k) K994192

IMPREGUM PENTA M MONOSOFT by Espe Dental AG — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2000
Date Received
December 13, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
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)
  • K002364 — PROTEMP H (August 10, 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)
  • K994193 — IMPREGUM PENTA DUOSOFT (January 28, 2000)
  • K994190 — IMPREGUM GARANT L DUOSOFT (January 27, 2000)

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