Astek
Pro-Matrix Sample Pack (1 x Narrow Curve + 1 x Wide Curve)
13manufacturers in China registered for this device type
13catalogue numbers in this listing
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 | Young Innovations Inc., United States |
|---|---|
| FDA product code | JEP |
| Device type | Retainer, Matrix |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-02-03 |
| Record revised | 2026-05-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Inner pack of 20, case of 60, case of 32, package of 50, package of 2, case of 336 |
| Distribution end date | 2023-05-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 19021 | In distribution | |
| 19026 | In distribution | |
| 19000 | In distribution | |
| 19028 | In distribution | |
| 19025 | In distribution | |
| 19022 | In distribution | |
| 19006 | In distribution | |
| 19001 | In distribution | |
| 19027 | In distribution | |
| 100299 | In distribution | |
| 19005 | In distribution | |
| 19023 | Withdrawn | |
| 19024 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Composi-Tight® | Garrison Dental Solutions, L.L.C. | 172 |
| Bioclear Evolve | Bioclear Matrix Systems, LLC | 54 |
| 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 |
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.