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510(k) K973265

VERABOND 2V by Aalba Dent, Inc. — Product Code EJH

K973265 is an FDA 510(k) premarket notification submitted by Aalba Dent, Inc. for the device "VERABOND 2V". The FDA issued a decision of Substantially Equivalent on October 16, 1997. The device falls under product code EJH (Alloy, Metal, Base), a Class II device regulated under 21 CFR 872.3710. Aalba Dent, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1997
Date Received
August 29, 1997
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 Aalba Dent, Inc.

  • K040180 — CONTINUM V (March 4, 2004)
  • K040179 — CONTINUM (March 3, 2004)
  • K033356 — VERASOFT ES (December 30, 2003)
  • K982094 — VERABOND 2 (July 22, 1998)
  • K972971 — NPG + 2 (January 5, 1998)
  • K972607 — PLATALLOY (October 10, 1997)
  • K972533 — VERA SOLDER (September 5, 1997)
  • K972534 — ALFALLOY (September 5, 1997)
  • K972632 — VERA PD SOLDER (August 15, 1997)
  • K972532 — AALBA GOLD SOLDER (August 15, 1997)

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