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510(k) K820181

SYBRON/KERR CONTOUR by Sybron Corp. — Product Code EJJ

K820181 is an FDA 510(k) premarket notification submitted by Sybron Corp. for the device "SYBRON/KERR CONTOUR". The FDA issued a decision of Substantially Equivalent on February 24, 1982. The device falls under product code EJJ (Alloy, Amalgam), a Class II device regulated under 21 CFR 872.3070. Sybron Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1982
Date Received
January 22, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Amalgam
Device Class
Class II
Regulation Number
872.3070
Review Panel
DE
Submission Type

Other clearances by Sybron Corp.

  • K862284 — SEALITE (June 23, 1986)
  • K854855 — PROOF ALGINATE IMPRESSION MATERIAL (January 30, 1986)
  • K844092 — DIAGNOSTIC MICROSOPCE SLIDES (October 25, 1984)
  • K842132 — TYCOS SELF-CHECK/DIGITAL FEVER THERMO (July 18, 1984)
  • K841910 — KERR SEALAPEX ROOT CANAL SEALER (July 13, 1984)
  • K841732 — LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM (June 5, 1984)
  • K840469 — TYCOS SELF CHECK BPM3 BLOOD PRESS MONI (May 21, 1984)
  • K840407 — KERR RESIN BONDED BRIDGE CEMENT (May 21, 1984)
  • K840607 — LF MOTORIZED RADIOGRAPHIC FILM VIEWER (March 5, 1984)
  • K833138 — DIGITAL INJECTOR SYS (November 14, 1983)

Other clearances for product code EJJ

  • K053114 — SILVERFIL (November 15, 2005)
  • K051010 — SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 (May 2, 2005)
  • K033434 — BESTALOY (November 12, 2003)
  • K032152 — BENCO ADMIX (August 6, 2003)
  • K031658 — BENCO SPHERICAL (July 29, 2003)
  • K020452 — HIGH SILVER CONVENTIONAL (May 7, 2002)
  • K011801 — FUTURA TOPCAP NON GAMMA-2 (August 16, 2001)
  • K002810 — ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY (October 31, 2000)
  • K002811 — ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY (October 31, 2000)
  • K002808 — ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY (October 31, 2000)

FDA data resources