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510(k) K011801

FUTURA TOPCAP NON GAMMA-2 by Ab Ardent — Product Code EJJ

K011801 is an FDA 510(k) premarket notification submitted by Ab Ardent for the device "FUTURA TOPCAP NON GAMMA-2". The FDA issued a decision of Substantially Equivalent on August 16, 2001. The device falls under product code EJJ (Alloy, Amalgam), a Class II device regulated under 21 CFR 872.3070. Ab Ardent has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2001
Date Received
June 8, 2001
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 Ab Ardent

  • K131753 — MERIDIAN (November 14, 2013)
  • K040465 — LATIT FLOW (July 20, 2004)
  • K022971 — MICROHYBRID 11 (November 25, 2002)
  • K022975 — ETCHING 15 (November 22, 2002)
  • K022973 — ADHESIVE 14 (November 22, 2002)
  • K022972 — MICROFILL 13 (November 22, 2002)
  • K022974 — MICROHYBRID 12 (November 22, 2002)
  • K020452 — HIGH SILVER CONVENTIONAL (May 7, 2002)
  • K991974 — FUTURA GLASS IONOMER SILVER REINFORCED (September 17, 1999)
  • K982458 — VIVALLOY HR (August 24, 1998)

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)
  • 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)
  • K002810 — ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY (October 31, 2000)
  • K991481 — PARAGON (August 11, 1999)

FDA data resources