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510(k) K992048

MODIFICATION OF PROMPT L-POP by Espe Dental AG — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1999
Date Received
June 17, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
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)
  • K994192 — IMPREGUM PENTA M MONOSOFT (January 28, 2000)
  • K994193 — IMPREGUM PENTA DUOSOFT (January 28, 2000)

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