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510(k) K790866

14 KARAT CASTING GOLD by Williams Gold Refining Co., Inc. — Product Code EJT

K790866 is an FDA 510(k) premarket notification submitted by Williams Gold Refining Co., Inc. for the device "14 KARAT CASTING GOLD". The FDA issued a decision of Substantially Equivalent on June 15, 1979. The device falls under product code EJT (Alloy, Gold-Based Noble Metal), a Class II device regulated under 21 CFR 872.3060. Williams Gold Refining Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1979
Date Received
May 7, 1979
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 Williams Gold Refining Co., Inc.

  • K855182 — ALLOY FOR METAL CROWN & BRIDGE YELLOW PD #46 & #65 (March 25, 1986)
  • K860439 — DW217 #18 CROWN/BRIDGE & DW218 #24 CERAMIC ALLOYS (March 20, 1986)
  • K854738 — SPARTAN SOLDER (March 6, 1986)
  • K852895 — CERAMIC ALLOY NO. DW 179 (October 21, 1985)
  • K852093 — ALLOY 7 (August 23, 1985)
  • K850699 — SPARTAN -ALLOY FOR PORCELAIN FUSED TO METAL (March 18, 1985)
  • K844395 — RENAISSANCE (January 9, 1985)
  • K844394 — RENAISSANCE BONDING AGENT (January 9, 1985)
  • K822419 — NEW CROWN AND BRIDGE ALLOY NO. DW196 (August 30, 1982)
  • K821510 — A THENIUM (June 9, 1982)

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