Home / 510(k) Clearances / K922203

510(k) K922203

IPT CAPSULE MIXER by Ipt Technologies, Inc. — Product Code EFD

K922203 is an FDA 510(k) premarket notification submitted by Ipt Technologies, Inc. for the device "IPT CAPSULE MIXER". The FDA issued a decision of Substantially Equivalent on June 3, 1992. The device falls under product code EFD (Amalgamator, Dental, Ac-Powered), a Class I device regulated under 21 CFR 872.3100.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1992
Date Received
May 11, 1992
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 for product code EFD

  • K991913 — PENTAMIX 2 (July 26, 1999)
  • K923974 — SILIMAT PLUS (October 6, 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