DDS Dentin Desensitizer System with Fluoride
AMERICAN DENTAL PRODUCTS INC · Model G6 · UDI-DI 00865849000211
Description
A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-26 | 3M Unitek Corporation | Due to an increase of complaints for bracket bond failures and skin irritation or blistering. |
| 2022-06-01 | Ultradent Products, Inc. | SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer. |
| 2017-09-28 | Cosmedent, Inc. | Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material. |
| 2016-11-03 | Voco GmbH | Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive. |
| 2014-07-16 | Novocol, Inc. | Septodont is recalling Self-Etch bond because the material was incorrectly packaged. |
| 2014-07-16 | Novocol, Inc. | Septodont is recalling Self-Etch bond because the material was incorrectly packaged. |
| 2012-05-24 | Ultradent Products, Inc. | Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10, 2012, stating that a syringe of Peak SE Primer was mislabeled as Peak LC Bond Res |
| 2010-05-27 | Kerr Corporation | 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. |
| 2009-08-24 | Sybron Dental Specialties | Some of the material has been found to be gelled and therefore becomes unusable. |
| 2007-07-09 | Heraeus Kulzer Inc., Dental Products Division | The material may solidify in the bottle, and thus be rendered unusable. |
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