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510(k) K914339

DENTOMAT 3 AMALGAMATORS by Degussa AG — Product Code EFD

K914339 is an FDA 510(k) premarket notification submitted by Degussa AG for the device "DENTOMAT 3 AMALGAMATORS". The FDA issued a decision of Substantially Equivalent on November 7, 1991. The device falls under product code EFD (Amalgamator, Dental, Ac-Powered), a Class I device regulated under 21 CFR 872.3100. Degussa AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1991
Date Received
September 27, 1991
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 Degussa AG

  • K973288 — STABILOR HN (November 19, 1997)
  • K972910 — PORS ON LITE (October 14, 1997)
  • K960256 — DEGUDENT LS (February 21, 1996)
  • K960226 — DG 88 (February 14, 1996)
  • K960104 — BIOCCLUS 4 (February 6, 1996)
  • K955465 — DEGUPRINT (December 28, 1995)
  • K955118 — DEGUBOND X-LITE PLUS (December 11, 1995)
  • K955027 — DEGUBOND X-LITE (December 1, 1995)
  • K953344 — DEGUBOND ULTRA (August 25, 1995)
  • K951789 — PALLIAG NF IV (June 14, 1995)

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)
  • K914341 — MIXOMAT AMALGAMATOR (November 13, 1991)
  • K914340 — DUOMAT 3 AMALGAMATOR (November 13, 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