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510(k) K910632

ACCU-MIX AMALGAMATOR by Wykle Research, Inc. — Product Code EFD

K910632 is an FDA 510(k) premarket notification submitted by Wykle Research, Inc. for the device "ACCU-MIX AMALGAMATOR". The FDA issued a decision of Substantially Equivalent on March 15, 1991. The device falls under product code EFD (Amalgamator, Dental, Ac-Powered), a Class I device regulated under 21 CFR 872.3100. Wykle Research, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1991
Date Received
February 13, 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 Wykle Research, Inc.

  • K952670 — CUPRALLOY (August 25, 1995)
  • K921571 — 1ST IMPRESSION (September 10, 1993)

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)
  • 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