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510(k) K910065

GDC-3200 DENTAL SOLDER by Deringer-Ney, Inc. — Product Code EJT

K910065 is an FDA 510(k) premarket notification submitted by Deringer-Ney, Inc. for the device "GDC-3200 DENTAL SOLDER". The FDA issued a decision of Substantially Equivalent on March 15, 1991. The device falls under product code EJT (Alloy, Gold-Based 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
March 15, 1991
Date Received
January 9, 1991
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 Deringer-Ney, Inc.

  • K933178 — GDC 3509 (October 14, 1993)
  • K930482 — DENTAL CASTING ALLOY, MODIFICATION - PF-3 (March 31, 1993)
  • K930481 — DENTAL CASTING ALLOY MODIFICATION-PF-4 (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)
  • K904695 — GDC-1501 (January 2, 1991)
  • K904614 — GDC-1475 (December 19, 1990)
  • K901532 — GDC 3084 CASTING ALLOY (May 2, 1990)

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)
  • K033279 — GOLD DENTAL CASTING ALLOYS (January 15, 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)

FDA data resources