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510(k) K010381

D.SIGN 30 by Ivoclar North America, Inc. — Product Code EJH

K010381 is an FDA 510(k) premarket notification submitted by Ivoclar North America, Inc. for the device "D.SIGN 30". The FDA issued a decision of Substantially Equivalent on March 6, 2001. The device falls under product code EJH (Alloy, Metal, Base), a Class II device regulated under 21 CFR 872.3710. Ivoclar North America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2001
Date Received
February 8, 2001
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 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)
  • K011023 — D.SIGN 96 (May 2, 2001)
  • K011022 — BIOUNIVERSAL PDF (May 2, 2001)
  • K010250 — TETRIC CERAM HB (February 28, 2001)
  • K003293 — EXCITE DSC (February 6, 2001)
  • K003407 — SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) (January 26, 2001)
  • K003635 — DW 276 #3 (December 22, 2000)

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