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510(k) K801342

DISPOSABLE ARTICULATOR by Williams Gold Refining Co., Inc. — Product Code EJP

K801342 is an FDA 510(k) premarket notification submitted by Williams Gold Refining Co., Inc. for the device "DISPOSABLE ARTICULATOR". The FDA issued a decision of Substantially Equivalent on July 8, 1980. The device falls under product code EJP (Articulators), a Class I device regulated under 21 CFR 872.3150. Williams Gold Refining Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1980
Date Received
June 5, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Articulators
Device Class
Class I
Regulation Number
872.3150
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 EJP

  • K926190 — ALRAND INC. (DENTAL HAND INSTRUMENTS) (January 18, 1994)
  • K896131 — GNATHOMAT ARTICULATOR (December 4, 1989)
  • K892373 — DENTAL PLASTIC BITE FORK (June 12, 1989)
  • K884418 — PREMIER DIE-TRAK ARTICULATOR (November 14, 1988)
  • K872943 — DISPOSABLE ARTICULATOR (August 11, 1987)
  • K863009 — GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX (September 25, 1986)
  • K854702 — PLASTIC MOUNTING RINGS (March 6, 1986)
  • K833039 — HANDY IIM (October 4, 1983)
  • K811075 — BALANCE ARTICULATOR (May 13, 1981)
  • K810971 — THE GNATOMET (May 5, 1981)

FDA data resources