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510(k) K040465

LATIT FLOW by Ab Ardent — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2004
Date Received
February 23, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

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  • K022974 — MICROHYBRID 12 (November 22, 2002)
  • K022973 — ADHESIVE 14 (November 22, 2002)
  • K020452 — HIGH SILVER CONVENTIONAL (May 7, 2002)
  • K011801 — FUTURA TOPCAP NON GAMMA-2 (August 16, 2001)
  • K991974 — FUTURA GLASS IONOMER SILVER REINFORCED (September 17, 1999)
  • K982460 — VIVACAP HR (August 24, 1998)

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