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510(k) K020898

D.SIGN 15 (DW286 B) by Ivoclar Vivadent, Inc. — Product Code EJH

K020898 is an FDA 510(k) premarket notification submitted by Ivoclar Vivadent, Inc. for the device "D.SIGN 15 (DW286 B)". The FDA issued a decision of Substantially Equivalent on March 29, 2002. The device falls under product code EJH (Alloy, Metal, Base), a Class II device regulated under 21 CFR 872.3710. Ivoclar Vivadent, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2002
Date Received
January 24, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Metal, Base
Device Class
Class II
Regulation Number
872.3710
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 EJH

  • K123929 — BEGOPAL+ (March 14, 2013)
  • K040180 — CONTINUM V (March 4, 2004)
  • K040179 — CONTINUM (March 3, 2004)
  • K033356 — VERASOFT ES (December 30, 2003)
  • K033045 — DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST (December 23, 2003)
  • K032136 — WIROBOND C (September 4, 2003)
  • K031627 — NANO-TICROWN (June 11, 2003)
  • K030632 — PD CASTA-H (May 7, 2003)
  • K030416 — CERACAST-V (April 14, 2003)
  • K030161 — SUPERBOND (March 17, 2003)

FDA data resources