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510(k) K991974

FUTURA GLASS IONOMER SILVER REINFORCED by Ab Ardent — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1999
Date Received
June 11, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

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  • K022972 — MICROFILL 13 (November 22, 2002)
  • K022975 — ETCHING 15 (November 22, 2002)
  • K022973 — ADHESIVE 14 (November 22, 2002)
  • K022974 — MICROHYBRID 12 (November 22, 2002)
  • K020452 — HIGH SILVER CONVENTIONAL (May 7, 2002)
  • K011801 — FUTURA TOPCAP NON GAMMA-2 (August 16, 2001)
  • K982458 — VIVALLOY HR (August 24, 1998)

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