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510(k) K872746

VITALLIUM WIRE by Austenal Dental, Inc. — Product Code EJW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1987
Date Received
July 13, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clasp, Wire
Device Class
Class I
Regulation Number
872.3285
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)
  • 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)

Other clearances for product code EJW

  • K901257 — WIRONTOM CLASP WIRE (April 25, 1990)
  • K881331 — ORTHODONTIC NITINOL SPRINGS (April 21, 1988)