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510(k) K771901

CAPMIX by Espe Dental Products — Product Code EFD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1977
Date Received
October 7, 1977
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 Products

  • K810950 — VISIO-SEAL (April 29, 1981)
  • K802819 — KETAC-CEM IN REF. TO K802048 (November 24, 1980)
  • K802049 — NIMETIC-DISPERS (September 16, 1980)
  • K800031 — PERMADYNE POLYETHER RUBBER IMPRESSION (February 5, 1980)
  • K771889 — UNIOLITE (October 20, 1977)
  • K771120 — IMPREFLEX ALGINATE IMPRESSION MATERIAL (August 3, 1977)
  • K771119 — PASTES, RESTORATIVE & TINTED, DEBTAL (July 15, 1977)

Other clearances for product code EFD

  • K991913 — PENTAMIX 2 (July 26, 1999)
  • 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)