Band-Lok® Blue

Band-Lok® is a two paste dual-cure adhesive intended for use as a band cement. Band-Lok Product Features: No messy Powder-Liquid Systems. Consistent mix viscosity every time. Unlike Glass…

Registry build 21.09.26

Band-Lok® is a two paste dual-cure adhesive intended for use as a band cement. Band-Lok Product Features: No messy Powder-Liquid Systems. Consistent mix viscosity every time. Unlike Glass Monomer cements, Band-Lok does not have an aftertaste or odor. Better adhesion to enamel and band surfaces is achieved, reducing washout and preventing loose bands. Four minute working time at room temperature without a frozen slab. Band-Lok is a Dual Cure cement. It can be used with or without a dental curing light. When band is placed and flash is cleaned a 20 second light activation allows full protection from moisture. Without light activation a complete set is achieved in 10 minutes. Superior Adhesion/Reduced Washout: Band-Lok and Ultra Band-Lok are a unique combination of Resin and Glass Ionomer technology. Band-Lok is Fluoride releasing. Contents of Kit: •(4) 6gm. Syringes of Part A Blue Paste •(4) 6gm. Syringes of Part B Paste •Mixing Pads and Spatulas.

10manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (3), Shandong (2), Jilin (2).

Chinese manufacturers registered for FDA product code EBF
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

Regulatory record for Band-Lok® Blue
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 2018-11-14
Record revised 2020-07-24 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Supplied as a kit Yes
Storage Special storage condition: TEMPERATURE LIMITATION: Store refrigerated (2-8 degrees C.)

Catalogue Numbers

Catalogue numbers for Band-Lok® Blue
Catalogue number Size Status
NFBLB In distribution
BLB In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer