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510(k) K901909

SILAMAT (AMALGAMATOR) by Ivoclar North America, Inc. — Product Code EFD

K901909 is an FDA 510(k) premarket notification submitted by Ivoclar North America, Inc. for the device "SILAMAT (AMALGAMATOR)". The FDA issued a decision of Substantially Equivalent on June 22, 1990. The device falls under product code EFD (Amalgamator, Dental, Ac-Powered), a Class I device regulated under 21 CFR 872.3100. Ivoclar North America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1990
Date Received
April 27, 1990
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 Ivoclar North America, Inc.

  • K012174 — ERIS LAYERING MATERIALS (August 27, 2001)
  • K011491 — HELIOSEAL CLEAR CHROMA (August 16, 2001)
  • K011492 — IN TEN-S (July 5, 2001)
  • K011490 — MODIFICATION TO EXCITE (June 27, 2001)
  • K011022 — BIOUNIVERSAL PDF (May 2, 2001)
  • K011023 — D.SIGN 96 (May 2, 2001)
  • K010381 — D.SIGN 30 (March 6, 2001)
  • K010250 — TETRIC CERAM HB (February 28, 2001)
  • K003293 — EXCITE DSC (February 6, 2001)
  • K003407 — SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) (January 26, 2001)

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)
  • K891612 — DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA. (June 12, 1989)
  • K891064 — ESPE CAPMIX (May 30, 1989)

FDA data resources