The aligner attachment kit is intended for use in the creation of molds for thermoplastic alligners. The Oval Attachment Form can be used for the retention of the thermoplastic aligners and…
The aligner attachment kit is intended for use in the creation of molds for thermoplastic alligners. The Oval Attachment Form can be used for the retention of the thermoplastic aligners and for horizontal or vertical placement on the tooth depending on the height of the crown. The Rectangle Attachment Form can be used for individual tooth movement and for extrusion of teeth. The Assure Bonding Resin included will bond to all intraoral surfaces without additional primers. L.C.R. Light Cure Paste cures smooth as glass for patient comfort. It has a very high Barcol Hardness for long term durability.
Who Else Makes It
Concentrated in Jilin (2), Liaoning (1), Guangdong (1).
Record
Regulatory record for A2 | 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 | 2016-07-25 |
| Record revised | 2024-02-16 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store at room temperature |
| Distribution end date | 2017-09-07 |
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.