Home / 510(k) Clearances / K131753

510(k) K131753

MERIDIAN by Ab Ardent — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2013
Date Received
June 14, 2013
Clearance Type
Abbreviated
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

Other clearances by Ab Ardent

  • K040465 — LATIT FLOW (July 20, 2004)
  • K022971 — MICROHYBRID 11 (November 25, 2002)
  • 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)
  • K991974 — FUTURA GLASS IONOMER SILVER REINFORCED (September 17, 1999)
  • K982458 — VIVALLOY HR (August 24, 1998)

Other clearances for product code EBF

  • K260783 — Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One (March 11, 2026)
  • K254245 — ZAFIRA® (March 3, 2026)
  • K260170 — LumiCera (January 21, 2026)
  • K252465 — Any-Core (December 5, 2025)
  • K253513 — MultiMatch Flow Chameleon AntiMicrobial Composite (November 7, 2025)
  • K253236 — G-BLOCK (September 29, 2025)
  • K253053 — Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) (September 23, 2025)
  • K251946 — G aenial Universal Injectable II (August 29, 2025)
  • K251283 — Once-Fil Flow (June 6, 2025)
  • K250317 — EsFlow PLUS (May 30, 2025)