Home / 510(k) Clearances / K032136

510(k) K032136

WIROBOND C by Bego U.S.A. — Product Code EJH

K032136 is an FDA 510(k) premarket notification submitted by Bego U.S.A. for the device "WIROBOND C". The FDA issued a decision of Substantially Equivalent on September 4, 2003. The device falls under product code EJH (Alloy, Metal, Base), a Class II device regulated under 21 CFR 872.3710. Bego U.S.A. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2003
Date Received
July 11, 2003
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 Bego U.S.A.

  • K033279 — GOLD DENTAL CASTING ALLOYS (January 15, 2004)
  • K983082 — BEGOCER G (October 28, 1998)
  • K983080 — AUROLLOYD KF (October 28, 1998)
  • K983077 — BIO PONTOSTAR (October 23, 1998)
  • K983079 — PLATINLLOYD 100 (October 23, 1998)
  • K983078 — BEGOPAL (October 23, 1998)

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)
  • K031627 — NANO-TICROWN (June 11, 2003)
  • K030632 — PD CASTA-H (May 7, 2003)
  • K030416 — CERACAST-V (April 14, 2003)
  • K030161 — SUPERBOND (March 17, 2003)
  • K024214 — KAVO EVEREST TITANBLANK (March 12, 2003)

FDA data resources