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510(k) K862856

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

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)
  • K862557 — AUSTENAL ACUSOFT SOFT LINER (February 19, 1987)
  • K865025 — AUSTENAL CONDENSING INSTRUMENT (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)

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  • K020194 — SIMIDUR KF PLUS (March 15, 2002)
  • K020195 — SIMIDUR S1S (March 15, 2002)
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