Artiste Se Flowable Composite, Model N280

• • Terminated Z-1115-2012 FDA Unclassified (pre-2012) ·initiated 19 Aug 2010

  A recall was initiated because Pentron Clinical has confirmed that the Fusio Liquid Dentin is not as flowable as ideally expected.

510(k) Number

K072545 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Fiberfill Sgp

  Class I

  FDA 510(k) K023819 Active Cleared 26 Mar 2003

• Trionomer

  Class II

  FDA 510(k) K022150 Active Cleared 21 Aug 2002

• Fiberfill AGP

  Class II

  FDA 510(k) K023818 Active Cleared 3 Apr 2003

• SE Epiphany Root Canal Sealant, Model N59SE

  Class II

  FDA 510(k) K060889 Active Cleared 27 Oct 2006

• Avante Led Curing Unit, Model N44

  Class II

  FDA 510(k) K052349 Active Cleared 21 Oct 2005

• Generation 8 Se Adhesive

  Class II

  FDA 510(k) K072480 Active Cleared 21 Nov 2007

See all devices from Pentron Clinical Technologies →