Ultra Band Lok
Ultra Band-Lok is intended for use as an orthodontic band cement and for occlusal buildups. Ultra Band-Lok can also be used to bond brackets, lingual retainers and large acrylic appliances.…
Ultra Band-Lok is intended for use as an orthodontic band cement and for occlusal buildups. Ultra Band-Lok can also be used to bond brackets, lingual retainers and large acrylic appliances. This product is in Blue Shade which will contrast the enamel and facilitate removal of material before and after treatment. Luer Lok Ultra Band Lok kit contains: 6 5g Luer Lok Blue Adhesive Syringes with 60 tips.
Who Else Makes It
Concentrated in Guangdong (3), Shandong (2), Jilin (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| Hangzhou SHINING3D Dental Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Shenzhen Piocreat 3D Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Shenzhen Upcera Dental Technology Co., Ltd. | Shenzhen | Guangdong | Private-label distributor | 6 |
| Sincera Technology (Changchun) Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
| Sino-Dentex Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
Record
| Listed by | Reliance Orthodontic Products, Inc., United States |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2016-08-05 |
| Record revised | 2019-04-26 (version 5) |
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 refrigerated (2-8 Degrees C) Avoid excessive heat. Allow product to reach room temperature prior to use. |
| Distribution end date | 2026-04-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LLUBLBP | In distribution | |
| NFLLUBLBPP | In distribution | |
| NFUBLPP | In distribution | |
| LLUBLP | In distribution | |
| 1LLUBLP | In distribution | |
| NFUBLBPP | In distribution | |
| 1NFLLUBLBPP | In distribution | |
| UBLB | Withdrawn | |
| NFLLUBLPP | Withdrawn | |
| UBLPP | Withdrawn | |
| UBLBPP | Withdrawn | |
| UBL | Withdrawn | |
| 1LLUBLBP | Withdrawn | |
| LLUBLB | Withdrawn | |
| LLUBL | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tooth Shade Resin Material | Liaoning Upcera Co., Ltd. | 4,808 |
| Gradia® | GC America Inc. | 548 |
| G-CAM | Graphenano Dental, SL | 320 |
| Vitavm LC | Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 261 |
| G-aenial™ | GC America Inc. | 225 |
| Ena HRI ® | Micerium SPA | 221 |
| Mazic Duro | Vericom Co., Ltd. | 206 |
| Ceramage | Shofu Dental Corp. | 204 |
| Filtek™ | 3M Company | 188 |
| SR Nexco | Ivoclar Vivadent Aktiengesellschaft | 181 |
| Aidite | Aidite (Qinhuangdao) Technology Co., Ltd. | 166 |
| Tetric EvoCeram | Ivoclar Vivadent Aktiengesellschaft | 163 |
Showing 12 of 2,059. All products under Material, Tooth Shade, Resin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210349 | 2021-07-20 |
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.