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510(k) K860911

AUSTENAL HYCO ALGINATE IMPRESSION MATERIAL by Austenal Dental, Inc. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1986
Date Received
March 11, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
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)
  • K862856 — PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR (August 26, 1986)

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