Home › Device types › KLE
Agent, Tooth Bonding, Resin
FDA product code KLE · Class 2 · Dental
1,607
Registered devices
1,159
Adverse events
20
Recalls
419
510(k) clearances
Devices with this code
Alpha-Bond® SE — DENTAL TECHNOLOGIES, INC.Vivid Ceramic Prime — PEARSON DENTAL SUPPLIES, INC.All-Bond 2 — BISCO INC.QUICKBOND — ITENA CLINICALDarby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLCTokuyama Universal Bond II — TOKUYAMA DENTAL CORPORATIONAELITE- Aesthetic Univ Syr Kit — BISCO INC.Henry Schein — HENRY SCHEIN, INC.e-1 Crimson 37% Phosphoric acid etchant gel — E DENTAL PRODUCTSSTAE — SDI LIMITEDVitique Silane — DMG Chemisch-Pharmazeutische Fabrik GmbHDia-X Bond Universal — DiaDent Group Internationale-1 Pink 37% Phosphoric acid etchant gel — E DENTAL PRODUCTSLucitone Digital Print™ — Dentsply International Inc.Fiber Technology — Preat CorporationParkell® — PARKELL, INC.Lucitone Digital Print™ — Dentsply International Inc.Uni-Etch w/BAC — BISCO INC.e-1 Pink 37% Phosphoric acid etchant gel — E DENTAL PRODUCTSOSE 8oz. Orthodontic Etching Gel - Blue — ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCMonobond Etch & Prime — IVOCLAR VIVADENT AKTIENGESELLSCHAFTPermaQuick — ULTRADENT PRODUCTS, INC.PRELUDE — DANVILLE MATERIALS, LLCJade — DHARMA RESEARCH, INC.
Recent 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 |
| 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 |
| 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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