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510(k) K791410

AMALGAMATOR MODEL SDC-- by Sierra Laboratories, Inc. — Product Code EFD

K791410 is an FDA 510(k) premarket notification submitted by Sierra Laboratories, Inc. for the device "AMALGAMATOR MODEL SDC--". The FDA issued a decision of Substantially Equivalent on September 19, 1979. The device falls under product code EFD (Amalgamator, Dental, Ac-Powered), a Class I device regulated under 21 CFR 872.3100. Sierra Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1979
Date Received
July 12, 1979
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 Sierra Laboratories, Inc.

  • K970966 — COMFORT CATH CHOICE MALE EXTERNAL CATHETER (April 22, 1997)
  • K962384 — COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER (July 15, 1996)
  • K962413 — COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER (July 15, 1996)
  • K934266 — COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER (April 19, 1994)
  • K934052 — ALPINE REUSABLE LEG BAGS (January 7, 1994)
  • K931156 — CONE CATH (July 1, 1993)
  • K901000 — URO TEX URINALS (March 26, 1990)
  • K883057 — COMFORT CATH MALE EXTERNAL CATHETER (August 2, 1988)
  • K873039 — MODEL 820 TOP=TRAK (February 11, 1988)
  • K832450 — URO-TEX MALE EXTERNAL CATHETER (October 14, 1983)

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)

FDA data resources