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510(k) K033279

GOLD DENTAL CASTING ALLOYS by Bego U.S.A. — Product Code EJT

K033279 is an FDA 510(k) premarket notification submitted by Bego U.S.A. for the device "GOLD DENTAL CASTING ALLOYS". The FDA issued a decision of Substantially Equivalent on January 15, 2004. The device falls under product code EJT (Alloy, Gold-Based Noble Metal), a Class II device regulated under 21 CFR 872.3060. Bego U.S.A. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2004
Date Received
October 10, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Gold-Based Noble Metal
Device Class
Class II
Regulation Number
872.3060
Review Panel
DE
Submission Type

Other clearances by Bego U.S.A.

  • K032136 — WIROBOND C (September 4, 2003)
  • 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 EJT

  • K052463 — PROMETAL HN86 (October 14, 2005)
  • K041378 — BIO 60 (August 2, 2004)
  • K040672 — PORTA REFLEX (May 27, 2004)
  • K040524 — PORTA SOLDER 1090 W (May 20, 2004)
  • K040043 — NDX-40 ALLOY (March 3, 2004)
  • K034049 — HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, (March 1, 2004)
  • K033446 — APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 (November 13, 2003)
  • K033435 — E-SARANG 86, DM78, DM55 (November 12, 2003)
  • K032320 — APPOLLO 3 ALLOY (October 1, 2003)
  • K032319 — CERA R PLUS ALLOY (September 30, 2003)

FDA data resources