Bioclear Evolve
54 catalogue numbers from Orange 7mm, listed by Bioclear Matrix Systems, LLC, United States, under Retainer, Matrix. 13 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Shanghai (6), Jiangsu (3), Guangdong (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Tessy Plastics Shanghai Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | Cangzhou | Hebei | Manufacturer | 40 |
| Astar Orthodontics Inc. | Shanghai | Shanghai | Manufacturer | 12 |
Showing 12 of 13. All 13 manufacturers in China registered for Retainer, Matrix
Record
| Listed by | Bioclear Matrix Systems, LLC, United States |
|---|---|
| FDA product code | JEP |
| Device type | Retainer, Matrix |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-08-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Orange 7mm | 25 | In distribution | |
| Black 10mm | 25 | In distribution | |
| Blue 9mm | 50 | In distribution | |
| Blue 9mm | 50 | In distribution | |
| Blue 5mm | 25 | In distribution | |
| Black 6mm | 50 | In distribution | |
| Orange 6mm | 25 | In distribution | |
| Blue 9mm | 25 | In distribution | |
| Black 7mm | 25 | In distribution | |
| Blue 8mm | 50 | In distribution | |
| Blue 6mm | 25 | In distribution | |
| Orange 9mm | 50 | In distribution | |
| Black 6mm | 25 | In distribution | |
| Pink 9mm | 25 | In distribution | |
| Pink 9mm | 25 | In distribution | |
| Pink 7mm | 50 | In distribution | |
| Blue 7mm | 25 | In distribution | |
| Black 8mm | 25 | In distribution | |
| Blue 6mm | 50 | In distribution | |
| Orange 7mm | 25 | In distribution | |
| Blue 5mm | 25 | In distribution | |
| Orange 6mm | 50 | In distribution | |
| Black 10mm | 50 | In distribution | |
| Blue 5mm | 50 | In distribution | |
| Blue 8mm | 25 | In distribution | |
| Black 7mm | 50 | In distribution | |
| Black 8mm | 50 | In distribution | |
| Pink 6mm | 25 | In distribution | |
| Pink 6mm | 50 | In distribution | |
| Pink 7mm | 50 | In distribution | |
| Black 5mm | 50 | In distribution | |
| Orange 9mm | 25 | In distribution | |
| Blue 7mm | 50 | In distribution | |
| Orange 6mm | 25 | In distribution | |
| Black 5mm | 25 | In distribution | |
| Pink 9mm | 50 | In distribution | |
| Blue 7mm | 50 | In distribution | |
| Blue 6mm | 50 | In distribution | |
| Blue 9mm | 25 | In distribution | |
| Blue 7mm | 25 | In distribution | |
| Blue 8mm | 25 | In distribution | |
| Blue 6mm | 25 | In distribution | |
| Pink 6mm | 50 | In distribution | |
| Orange 7mm | 50 | In distribution | |
| Pink 6mm | 25 | In distribution | |
| Blue 5mm | 50 | In distribution | |
| Orange 9mm | 50 | In distribution | |
| Pink 7mm | 25 | In distribution | |
| Orange 9mm | 25 | In distribution | |
| Blue 8mm | 50 | In distribution | |
| Orange 6mm | 50 | In distribution | |
| Pink 9mm | 50 | In distribution | |
| Pink 7mm | 25 | In distribution | |
| Orange 7mm | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Composi-Tight® | Garrison Dental Solutions, L.L.C. | 172 |
| Slick Bands™ | Garrison Dental Solutions, L.L.C. | 52 |
| Henry Schein | Henry Schein, Inc. | 47 |
| Halo Sectional Matrix System | Ultradent Products Inc. | 44 |
| Black Triangle Matrix | Bioclear Matrix Systems, LLC | 42 |
| HD Anterior Matrix A Series | Bioclear Matrix Systems, LLC | 37 |
| Strata-G™ | Garrison Dental Solutions, L.L.C. | 33 |
| NiTin Garrison® | Garrison Dental Solutions, L.L.C. | 33 |
| White Bite | White Bite, Inc. | 30 |
| Denovo Preformed Matrix Band | Denovo Dental Inc | 30 |
| Quad Matrix System™ | Garrison Dental Solutions, L.L.C. | 26 |
| Original Anterior Matrix A Series | Bioclear Matrix Systems, LLC | 25 |
Showing 12 of 102. All products under Retainer, Matrix
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.