Dentin Conditioning and Adhesive (Bond 1)

• • Terminated Z-1142-2012 FDA Unclassified (pre-2012) ·initiated 27 May 2010

  The recall was initiated because Pentron Clinical has confirmed that various lots of Bond-1 Primer/Adhesive have been found to have gelled and therefore becomes unusable.

• • Terminated Z-1150-2010 FDA Unclassified (pre-2012) ·initiated 24 Aug 2009

  Some of the material has been found to be gelled and therefore becomes unusable.

510(k) Number

K973388 ↗

FDA Product Code

KLE

Device Class

Class II

Regulation

21 CFR Part 872.3200

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K922958 Active Cleared 26 Feb 1993

• Prop. Conquest C&B Vlc Glaze/Sealant

  Class II

  FDA 510(k) K953381 Active Cleared 27 Sep 1995

• Crown and Bridge Dental Restorative Composite Syst

  Class II

  FDA 510(k) K894644 Active Cleared 20 Oct 1989

• Orosphere Hcdp

  Class II

  FDA 510(k) K890681 Active Cleared 2 May 1989

• Conquest Crystal

  Class II

  FDA 510(k) K932154 Active Cleared 15 Sep 1993

• Bond-It Dual Cure Activator

  Class II

  FDA 510(k) K953859 Active Cleared 7 Sep 1995

See all devices from Jeneric/Pentron, Inc. →

• What is Dentin Conditioning and Adhesive (Bond 1) used for?

  It is a dental agent used for tooth bonding, specifically a resin-based bonding agent designed to condition dentin and provide adhesion for restorative materials during dental procedures.

• How is Dentin Conditioning and Adhesive (Bond 1) supplied?

  It is supplied as a single-bottle primer/adhesive system, meaning both conditioning and adhesive functions are combined in one bottle for use in dental settings.

• Is Dentin Conditioning and Adhesive (Bond 1) sterile or single-use?

  The device data does not specify sterility or single-use status; it is described as a dental agent supplied in a bottle for use in dental procedures, but no details about sterility or reuse are provided.

• What regulatory clearance does Dentin Conditioning and Adhesive (Bond 1) have?

  It has received FDA 510(k) clearance under K973388, with product code KLE and regulation number 872.3200, classified as substantially equivalent to a predicate device.