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510(k) K991913

PENTAMIX 2 by Espe Dental AG — Product Code EFD

K991913 is an FDA 510(k) premarket notification submitted by Espe Dental AG for the device "PENTAMIX 2". The FDA issued a decision of Substantially Equivalent on July 26, 1999. The device falls under product code EFD (Amalgamator, Dental, Ac-Powered), a Class I device regulated under 21 CFR 872.3100. Espe Dental AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1999
Date Received
June 7, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amalgamator, Dental, Ac-Powered
Device Class
Class I
Regulation Number
872.3100
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)
  • K000588 — DIMENSION GARANT L, DIMENSION GARANT L QUICK (March 30, 2000)
  • K000591 — DIMENSION PENTA H, DIMENSION PENTA H QUICK (March 30, 2000)
  • K994193 — IMPREGUM PENTA DUOSOFT (January 28, 2000)
  • K994192 — IMPREGUM PENTA M MONOSOFT (January 28, 2000)

Other clearances for product code EFD

  • K923974 — SILIMAT PLUS (October 6, 1992)
  • K922203 — IPT CAPSULE MIXER (June 3, 1992)
  • K915847 — AUTOMIX DENTAL AMALGAMATOR (March 2, 1992)
  • K914340 — DUOMAT 3 AMALGAMATOR (November 13, 1991)
  • K914341 — MIXOMAT AMALGAMATOR (November 13, 1991)
  • K914339 — DENTOMAT 3 AMALGAMATORS (November 7, 1991)
  • K910632 — ACCU-MIX AMALGAMATOR (March 15, 1991)
  • K901909 — SILAMAT (AMALGAMATOR) (June 22, 1990)
  • K891612 — DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA. (June 12, 1989)
  • K891064 — ESPE CAPMIX (May 30, 1989)

FDA data resources