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510(k) K923974

SILIMAT PLUS by Ivoclar North America, Inc. — Product Code EFD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1992
Date Received
August 7, 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 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)
  • 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)
  • K891064 — ESPE CAPMIX (May 30, 1989)