Assure® Universal Bonding Resin is intended to increase adhesion to wet or dry, normal and atypical enamel surfaces including: hypocalcified, fluorosed, deciduous enamel and dentin. It will…
Assure® Universal Bonding Resin is intended to increase adhesion to wet or dry, normal and atypical enamel surfaces including: hypocalcified, fluorosed, deciduous enamel and dentin. It will bond to roughened metal (amalgam, gold or stainless steel) and composite restorations without additional primers. PRODUCT FEATURES: Assure® Universal Bonding Resin is hydrophilic so the etched enamel can be dry or slightly contaminated with saliva. Assure® Universal Bonding Resin does not require light activation (except on dentin). It can be used under any chemical, light cure or dual cure paste, regardless of manufacturer.
Who Else Makes It
Concentrated in Jilin (2), Liaoning (1), Guangdong (1).
Record
Regulatory record for Assure | Listed by | Reliance Orthodontic Products, Inc., United States |
| FDA product code | KLE |
| Device type | Agent, Tooth Bonding, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3200 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2016-06-28 |
| Record revised | 2026-05-29 (version 6) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Assure Universal Bonding Resin can be stored and handled at ambient temperatures |
| Distribution end date | 2026-05-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.