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510(k) K852895

CERAMIC ALLOY NO. DW 179 by Williams Gold Refining Co., Inc. — Product Code EJH

K852895 is an FDA 510(k) premarket notification submitted by Williams Gold Refining Co., Inc. for the device "CERAMIC ALLOY NO. DW 179". The FDA issued a decision of Substantially Equivalent on October 21, 1985. The device falls under product code EJH (Alloy, Metal, Base), a Class II device regulated under 21 CFR 872.3710. Williams Gold Refining Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1985
Date Received
July 9, 1985
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 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)
  • 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)
  • K811563 — PRESOLDER FOR NON-PRECIOUS DENTAL ALLOYS (July 28, 1981)

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)
  • K032136 — WIROBOND C (September 4, 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)

FDA data resources