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510(k) K865025

AUSTENAL CONDENSING INSTRUMENT by Austenal Dental, Inc. — Product Code EKG

K865025 is an FDA 510(k) premarket notification submitted by Austenal Dental, Inc. for the device "AUSTENAL CONDENSING INSTRUMENT". The FDA issued a decision of Substantially Equivalent on February 19, 1987. The device falls under product code EKG (Condenser, Amalgam And Foil, Operative), a Class I device regulated under 21 CFR 872.4565. Austenal Dental, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1987
Date Received
December 23, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condenser, Amalgam And Foil, Operative
Device Class
Class I
Regulation Number
872.4565
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)
  • 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 EKG

  • K843901 — ISOSTATIC CONDENSER (December 3, 1984)
  • K823322 — DENTAL INSTRUMENTS - PLUGGERS (November 24, 1982)

FDA data resources