Optibond Solo Plus 2

• • Terminated Z-1521-06 FDA Unclassified (pre-2012) ·initiated 29 Aug 2006

  Mis-pack/mis-label: The OptiBond Self Etch Primer and OptiBond Solo Plus Adhesive in the chambers were mis-packaged/mis-labeled in reverse order. Application of these products in reverse order may result in compromised bond strength.

• 8 recalls, same reason

  • Terminated Z-0693-06 FDA Unclassified (pre-2012) ·initiated 3 Mar 2006
  • Terminated Z-0686-06 FDA Unclassified (pre-2012) ·initiated 3 Mar 2006
  • Terminated Z-0690-06 FDA Unclassified (pre-2012) ·initiated 3 Mar 2006
  • Terminated Z-0691-06 FDA Unclassified (pre-2012) ·initiated 3 Mar 2006
  • Terminated Z-0689-06 FDA Unclassified (pre-2012) ·initiated 3 Mar 2006
  • Terminated Z-0688-06 FDA Unclassified (pre-2012) ·initiated 3 Mar 2006
  • Terminated Z-0692-06 FDA Unclassified (pre-2012) ·initiated 3 Mar 2006
  • Terminated Z-0687-06 FDA Unclassified (pre-2012) ·initiated 3 Mar 2006

  The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.

510(k) Number

K991808 ↗

FDA Product Code

KLE

Device Class

Class II

Regulation

21 CFR Part 872.3200

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Prodigy 4

  Class II

  FDA 510(k) K990898 Active Cleared 6 Apr 1999

• Kerr Gel Etchant

  Class II

  FDA 510(k) K000954 Active Cleared 28 Apr 2000

• Sealapex 4

  Class II

  FDA 510(k) K010940 Active Cleared 20 Jun 2001

• Point 4 Flowable

  Class II

  FDA 510(k) K012321 Active Cleared 27 Aug 2001

• Temp-Bond Ne 2

  Class II

  FDA 510(k) K003658 Active Cleared 4 Jan 2001

• Extrude

  Class II

  FDA 510(k) K940379 Active Cleared 22 Mar 1994

See all devices from Sybron Dental Specialties, Inc. →

• What is Optibond Solo Plus 2 used for?

  Optibond Solo Plus 2 is a dental bonding agent used in resin-based restorative procedures to bond composite materials to tooth structure, as specified in its FDA 510(k) clearance for tooth bonding applications.

• How is Optibond Solo Plus 2 supplied and packaged?

  The device is supplied as a single-component dental bonding agent for resin-based restorative procedures, though specific packaging details such as volume or container type are not provided in the authorization data.

• Is Optibond Solo Plus 2 intended for single-use or reuse?

  As a dental bonding agent applied directly to tooth surfaces during restorative procedures, Optibond Solo Plus 2 is intended for single-use per patient application to prevent cross-contamination, consistent with standard dental adhesive protocols.

• What regulatory pathway was used for Optibond Solo Plus 2?

  Optibond Solo Plus 2 received traditional 510(k) clearance (K991808) from the FDA on July 9, 1999, demonstrating substantial equivalence to a legally marketed predicate device under regulation 872.3200.

• What class of medical device is Optibond Solo Plus 2?

  Optibond Solo Plus 2 is classified as a Class II medical device under FDA regulation 872.3200, which governs agents, tooth bonding, resin for dental applications.