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510(k) K811563

PRESOLDER FOR NON-PRECIOUS DENTAL ALLOYS by Williams Gold Refining Co., Inc. — Product Code EJS

K811563 is an FDA 510(k) premarket notification submitted by Williams Gold Refining Co., Inc. for the device "PRESOLDER FOR NON-PRECIOUS DENTAL ALLOYS". The FDA issued a decision of Substantially Equivalent on July 28, 1981. The device falls under product code EJS (Alloy, Other 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
July 28, 1981
Date Received
June 4, 1981
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 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 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