Home › Device types › KLE
Agent, Tooth Bonding, Resin
FDA product code KLE · Class 2 · Dental
1,638
Registered devices
1,159
Adverse events
20
Recalls
421
510(k) clearances
Devices with this code
PRELUDE — DANVILLE MATERIALS, LLCAdhese Universal — IVOCLAR VIVADENT AKTIENGESELLSCHAFTSCOTT'S SELECT G-TYPE DESENSITIZER 10mL — SCOTT'S DENTAL SUPPLY L.L.C.IBOND UNIVERSAL SD SAMPLE 2 pcs — Kulzer GmbHTokuyama Universal Bond — TOKUYAMA DENTAL CORPORATIONAssure Plus — RELIANCE ORTHODONTIC PRODUCTS INCLucitone — Dentsply International Inc.Premier — PREMIER DENTAL PRODUCTS COMPANYDarby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLCG-Premio™ Bond — Gc America Inc.Choice 2 — BISCO INC.All-Bond 2 — BISCO INC.Tokuyama Universal Bond II — TOKUYAMA DENTAL CORPORATION3M™ Scotchbond™ — 3M Deutschland GmbHLucitone Digital Fuse™ — Dentsply International Inc.Ace All-Bond SE Cartridge-Pouch — BISCO INC.Lucitone Digital Fuse™ — Dentsply International Inc.IQ Dental — IQ DENTAL SUPPLY LLCASSURE PLUS ALL PURPOSE BONDING RESIN — FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INCTokuyama Universal Bond — TOKUYAMA DENTAL CORPORATIONC&C — RELIANCE ORTHODONTIC PRODUCTS INCTokuyama Universal Bond — TOKUYAMA DENTAL CORPORATIONPRIMER — FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INCBond-It — Kerr Corporation
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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