Dia-X Bond Universal is a universal adhesive capable of total, self, and selective etching as it consists of a single bottle of etching, primer, and adhesive resin. It can be used for both…
Dia-X Bond Universal is a universal adhesive capable of total, self, and selective etching as it consists of a single bottle of etching, primer, and adhesive resin. It can be used for both direct and indirect bonding of restorations.
Who Else Makes It
Concentrated in Jilin (2), Liaoning (1), Guangdong (1).
Record
Regulatory record for Dia-X Bond Universal | Listed by | Diadent Group Intl., Inc., Canada |
| FDA product code | KLE |
| Device type | Agent, Tooth Bonding, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3200 |
| Establishment | Repacker / relabeller, Private-label distributor, Manufacturer, Exporter |
| Record published | 2022-08-16 |
| Record revised | 2025-12-22 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 27 °C; Special storage condition: Keep Dry and away from Sunlight |
| UDI direct marking | Exempt |
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.