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510(k) K002793

KETAC CEM U by Espe Dental AG — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2000
Date Received
September 7, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

Other clearances by Espe Dental AG

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  • 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)
  • K994190 — IMPREGUM GARANT L DUOSOFT (January 27, 2000)

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