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510(k) K041433

BRIGHT GOLD XH by Ivoclar Vivadent, Inc. — Product Code EJS

K041433 is an FDA 510(k) premarket notification submitted by Ivoclar Vivadent, Inc. for the device "BRIGHT GOLD XH". The FDA issued a decision of Substantially Equivalent on August 19, 2004. The device falls under product code EJS (Alloy, Other Noble Metal), a Class II device regulated under 21 CFR 872.3060. Ivoclar Vivadent, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2004
Date Received
May 28, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Ivoclar Vivadent, Inc.

  • K261485 — Tetric plus Fill;Tetric plus Flow (July 1, 2026)
  • K253953 — IPS e.max Zirconia (March 10, 2026)
  • K252450 — Adhese 2 (March 5, 2026)
  • K233995 — Ivotion Base Print (February 23, 2024)
  • K210804 — Adhese Universal DC, Cention Primer (June 7, 2022)
  • K211916 — IPS e.max One (August 20, 2021)
  • K193193 — Telio CAD Abutment Solutions- extra systems (November 16, 2020)
  • K191453 — Cervitec F (February 11, 2020)
  • K191448 — Barrier Sleeves (October 8, 2019)
  • K191382 — IPS e.max CAD Abutment Solutions- extra systems (August 26, 2019)

Other clearances for product code EJS

  • K040436 — SIMIDUR SUPERIOR (March 5, 2004)
  • K022252 — STERNGOLD 1, MODEL 1127781 (September 19, 2002)
  • K022469 — ECO E4 (September 18, 2002)
  • K021367 — STERNGOLD 66, MODEL #1180230 (May 16, 2002)
  • K020195 — SIMIDUR S1S (March 15, 2002)
  • K020192 — SIMIDUR S2 (March 15, 2002)
  • K020194 — SIMIDUR KF PLUS (March 15, 2002)
  • K014042 — D.SIGN 84 (February 22, 2002)
  • K013809 — D.SIGN 59 (February 7, 2002)
  • K014082 — D.SIGN 53, MODEL NA1012204 (January 30, 2002)

FDA data resources