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510(k) K871288

GDC 1830 CASTING ALLOY by Deringer-Ney, Inc. — Product Code EJS

K871288 is an FDA 510(k) premarket notification submitted by Deringer-Ney, Inc. for the device "GDC 1830 CASTING ALLOY". The FDA issued a decision of Substantially Equivalent on April 15, 1987. The device falls under product code EJS (Alloy, Other Noble Metal), a Class II device regulated under 21 CFR 872.3060. Deringer-Ney, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1987
Date Received
March 31, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Deringer-Ney, Inc.

  • K933178 — GDC 3509 (October 14, 1993)
  • K930481 — DENTAL CASTING ALLOY MODIFICATION-PF-4 (March 31, 1993)
  • K930482 — DENTAL CASTING ALLOY, MODIFICATION - PF-3 (March 31, 1993)
  • K925273 — GDC 3445 (December 21, 1992)
  • K920922 — GDC 3367 (May 5, 1992)
  • K920060 — DENTAL SOLDER ALLOY (April 2, 1992)
  • K920887 — GDC-3338, DENTAL SOLDER ALLOY (March 19, 1992)
  • K910065 — GDC-3200 DENTAL SOLDER (March 15, 1991)
  • K904695 — GDC-1501 (January 2, 1991)
  • K904614 — GDC-1475 (December 19, 1990)

Other clearances for product code EJS

  • K041433 — BRIGHT GOLD XH (August 19, 2004)
  • K040436 — SIMIDUR SUPERIOR (March 5, 2004)
  • K022252 — STERNGOLD 1, MODEL 1127781 (September 19, 2002)
  • K022469 — ECO E4 (September 18, 2002)
  • K021367 — STERNGOLD 66, MODEL #1180230 (May 16, 2002)
  • K020195 — SIMIDUR S1S (March 15, 2002)
  • K020192 — SIMIDUR S2 (March 15, 2002)
  • K020194 — SIMIDUR KF PLUS (March 15, 2002)
  • K014042 — D.SIGN 84 (February 22, 2002)
  • K013809 — D.SIGN 59 (February 7, 2002)

FDA data resources