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510(k) K880875

VITALLIUM EQUIPOISE ALLOY by Austenal Dental, Inc. — Product Code EJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1988
Date Received
March 1, 1988
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 Austenal Dental, Inc.

  • K890713 — OVERDENTURE - STUD ATTACHMENT (July 14, 1989)
  • K883799 — BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN (October 20, 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)
  • K862856 — PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR (August 26, 1986)
  • K862667 — COBALT, 29.5% CHROMIUM ALLOY DENTAL BAKE-ON ALLOY (July 31, 1986)

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