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510(k) K862856

PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR by Austenal Dental, Inc. — Product Code EJS

K862856 is an FDA 510(k) premarket notification submitted by Austenal Dental, Inc. for the device "PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR". The FDA issued a decision of Substantially Equivalent on August 26, 1986. The device falls under product code EJS (Alloy, Other Noble Metal), a Class II device regulated under 21 CFR 872.3060. Austenal Dental, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1986
Date Received
July 29, 1986
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 Austenal Dental, Inc.

  • K890713 — OVERDENTURE - STUD ATTACHMENT (July 14, 1989)
  • K883799 — BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN (October 20, 1988)
  • K880875 — VITALLIUM EQUIPOISE ALLOY (April 7, 1988)
  • K871849 — LIGHT CURE DENTURE GLAZE (August 10, 1987)
  • K872746 — VITALLIUM WIRE (July 21, 1987)
  • K863630 — AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL (March 11, 1987)
  • K865025 — AUSTENAL CONDENSING INSTRUMENT (February 19, 1987)
  • K862557 — AUSTENAL ACUSOFT SOFT LINER (February 19, 1987)
  • K864826 — A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY) (February 10, 1987)
  • K862667 — COBALT, 29.5% CHROMIUM ALLOY DENTAL BAKE-ON ALLOY (July 31, 1986)

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