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EZ Bond Universal (EZB15)
Meta Biomed Co., Ltd. · Model 6008 · UDI-DI 08806387860082
KLE
Prescription
1
510(k) clearances
1,159
Adverse events
20
Recalls
142
Facilities
Description
EZ Bond Universal is dentin adhesion system that functions as a conditioner, primer and adhesive resin in a single component. EZB15 (1.5g)
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.