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510(k) K992897

IMPREGUM PENTA by Espe Dental AG — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1999
Date Received
August 27, 1999
Clearance Type
Special
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

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  • 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)
  • K994192 — IMPREGUM PENTA M MONOSOFT (January 28, 2000)
  • K994193 — IMPREGUM PENTA DUOSOFT (January 28, 2000)

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