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510(k) K012877

HIGH GOLD PALLADIUM FREE CERAMIC SOLDER by Ivoclar USA, Inc. — Product Code EJT

K012877 is an FDA 510(k) premarket notification submitted by Ivoclar USA, Inc. for the device "HIGH GOLD PALLADIUM FREE CERAMIC SOLDER". The FDA issued a decision of Substantially Equivalent on November 21, 2001. The device falls under product code EJT (Alloy, Gold-Based Noble Metal), a Class II device regulated under 21 CFR 872.3060. Ivoclar USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2001
Date Received
August 27, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Gold-Based Noble Metal
Device Class
Class II
Regulation Number
872.3060
Review Panel
DE
Submission Type

Other clearances by Ivoclar USA, Inc.

  • K981264 — ARISTON PHC (July 2, 1998)
  • K980986 — PROCAD (May 11, 1998)
  • K941849 — PROVIPONT C&B (August 17, 1994)
  • K923644 — DW243-64 (November 4, 1992)
  • K864708 — SR 3/60 NF DENTURE MATER. & SELF-CURE DENT. RESIN (February 25, 1987)
  • K864709 — IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL (February 10, 1987)
  • K864710 — ISOSIT N (February 10, 1987)
  • K864707 — SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH (February 10, 1987)
  • K863421 — SR-IVOLEN TRAY MATERIAL (November 3, 1986)
  • K844349 — SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS (December 3, 1984)

Other clearances for product code EJT

  • K052463 — PROMETAL HN86 (October 14, 2005)
  • K041378 — BIO 60 (August 2, 2004)
  • K040672 — PORTA REFLEX (May 27, 2004)
  • K040524 — PORTA SOLDER 1090 W (May 20, 2004)
  • K040043 — NDX-40 ALLOY (March 3, 2004)
  • K034049 — HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, (March 1, 2004)
  • K033279 — GOLD DENTAL CASTING ALLOYS (January 15, 2004)
  • K033446 — APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 (November 13, 2003)
  • K033435 — E-SARANG 86, DM78, DM55 (November 12, 2003)
  • K032320 — APPOLLO 3 ALLOY (October 1, 2003)

FDA data resources