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510(k) K932893

VIDENT 500 ALLOY AND VIDENT 550 BE ALLOY by Vident — Product Code EJH

K932893 is an FDA 510(k) premarket notification submitted by Vident for the device "VIDENT 500 ALLOY AND VIDENT 550 BE ALLOY". The FDA issued a decision of Substantially Equivalent on March 28, 1994. The device falls under product code EJH (Alloy, Metal, Base), a Class II device regulated under 21 CFR 872.3710. Vident has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1994
Date Received
June 10, 1993
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 Vident

  • K063768 — TITANIUM SCALLOPED ABUTMENT (June 27, 2007)
  • K060441 — VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX6 (April 27, 2006)
  • K052710 — VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 (January 13, 2006)
  • K052130 — VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40 (August 15, 2005)
  • K050362 — VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES) (March 15, 2005)
  • K022996 — VITA IN-CERAM YZ CUBES FOR CEREC (October 9, 2002)
  • K012473 — VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT (September 11, 2002)
  • K000597 — VITA RESPONSE (May 17, 2000)
  • K990367 — PDQ AND PDQ-TI ABUTMENT (April 21, 1999)
  • K984198 — WIDE BODY ABUTMENTS (February 18, 1999)

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