Crown Lok™ Blue is intended for use as a cement for metal crowns and orthodontic bands. Crown Lok is a self-curing two minute working time fluoride releasing cement. Crown Lok Kit contains…
Crown Lok™ Blue is intended for use as a cement for metal crowns and orthodontic bands. Crown Lok is a self-curing two minute working time fluoride releasing cement. Crown Lok Kit contains (4) 6gm Screw Blue Paste A Syringes and (4) 6gm Screw Paste B Syringes and a 9gm etch.
Who Else Makes It
Concentrated in Jilin (2), Liaoning (1), Guangdong (1).
Record
Regulatory record for Crown-Lok | 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 | 2025-10-09 (version 5) |
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 (15-30 C) |
| Distribution end date | 2019-07-01 |
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.