• Simple and fast application technique. • Compatible with all light-cured, and self-cured restorative materials and cements. • Long shelf-life with no need for refrigeration. • Economical.…
• Simple and fast application technique. • Compatible with all light-cured, and self-cured restorative materials and cements. • Long shelf-life with no need for refrigeration. • Economical. • No pulp irritation.
Who Else Makes It
Concentrated in Jilin (2), Liaoning (1), Guangdong (1).
Record
Regulatory record for Bonding Agent (Self-Cure) Part A & Part B | Listed by | Dent ZAR, Inc., United States |
| FDA product code | KLE |
| Device type | Agent, Tooth Bonding, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3200 |
| Establishment | Repacker / relabeller |
| 510(k) | K012794 |
| Record published | 2016-09-03 |
| Record revised | 2024-02-16 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
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.