Mini-Taurus
MIN TRS Trip Edge MX L W/H 022 11A -7T 4MO
52manufacturers in China registered for this device type
111catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (19), Guangdong (11), Jiangsu (9). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Chengdu Sani Medical Equipment Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 12 |
| Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Yancheng Denrum Medical Apparatus Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 5 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Shanghai MU Promotions Co., Ltd. | Shanghai | Shanghai | Exporter | 62 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
Showing 12 of 52. All 52 manufacturers in China registered for Bracket, Metal, Orthodontic
Record
| Listed by | RMO, United States |
|---|---|
| FDA product code | EJF |
| Device type | Bracket, Metal, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-09-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| M01656 | 10 | In distribution | |
| M01138 | 10 | In distribution | |
| M01108 | 10 | In distribution | |
| M01109 | 10 | In distribution | |
| M01105 | 10 | In distribution | |
| M01100 | 10 | In distribution | |
| M01131 | 10 | In distribution | |
| KM01102 | 20 | In distribution | |
| M01135 | 10 | In distribution | |
| M01657 | 10 | In distribution | |
| M01116 | 10 | In distribution | |
| KM01603 | 20 | In distribution | |
| M01677 | 10 | In distribution | |
| M01150 | 10 | In distribution | |
| KM01100 | 20 | In distribution | |
| M01162 | 10 | In distribution | |
| A06508 | 10 | In distribution | |
| M01610 | 10 | In distribution | |
| M01165 | 10 | In distribution | |
| M01104 | 10 | In distribution | |
| M01684 | 10 | In distribution | |
| M01655 | 10 | In distribution | |
| M01630 | 10 | In distribution | |
| A06529 | 10 | In distribution | |
| M01605 | 10 | In distribution | |
| M01680 | 10 | In distribution | |
| KS02000 | 20 | In distribution | |
| M01626 | 10 | In distribution | |
| M01674 | 10 | In distribution | |
| A06509 | 10 | In distribution | |
| M01143 | 10 | In distribution | |
| M01660 | 10 | In distribution | |
| KM01650 | 20 | In distribution | |
| M01601 | 10 | In distribution | |
| A06534 | 10 | In distribution | |
| M01653 | 10 | In distribution | |
| M01606 | 10 | In distribution | |
| M01676 | 10 | In distribution | |
| M01128 | 10 | In distribution | |
| M01164 | 10 | In distribution | |
| M01163 | 10 | In distribution | |
| M01140 | 10 | In distribution | |
| M01608 | 10 | In distribution | |
| M01110 | 10 | In distribution | |
| M01602 | 10 | In distribution | |
| M01651 | 10 | In distribution | |
| A06532 | 10 | In distribution | |
| M01121 | 10 | In distribution | |
| A06531 | 10 | In distribution | |
| M01634 | 10 | In distribution | |
| M01125 | 10 | In distribution | |
| M01644 | 10 | In distribution | |
| M01603 | 10 | In distribution | |
| M01141 | 10 | In distribution | |
| KM01101 | 20 | In distribution | |
| M01658 | 10 | In distribution | |
| M01130 | 10 | In distribution | |
| M01132 | 10 | In distribution | |
| KM01651 | 20 | In distribution | |
| KM01180 | 20 | In distribution | |
| M01117 | 10 | In distribution | |
| A06510 | 10 | In distribution | |
| M01629 | 10 | In distribution | |
| M01152 | 10 | In distribution | |
| M01627 | 10 | In distribution | |
| M01604 | 10 | In distribution | |
| M01126 | 10 | In distribution | |
| M01620 | 10 | In distribution | |
| M01609 | 10 | In distribution | |
| M01101 | 10 | In distribution | |
| M01134 | 10 | In distribution | |
| A06535 | 10 | In distribution | |
| M01142 | 10 | In distribution | |
| M01127 | 10 | In distribution | |
| KM01653 | 20 | In distribution | |
| M01670 | 10 | In distribution | |
| KM01600 | 20 | In distribution | |
| M01678 | 10 | In distribution | |
| M01159 | 10 | In distribution | |
| M01151 | 10 | In distribution | |
| M01153 | 10 | In distribution | |
| M01654 | 10 | In distribution | |
| M01158 | 10 | In distribution | |
| M01607 | 10 | In distribution | |
| M01659 | 10 | In distribution | |
| M01624 | 10 | In distribution | |
| M01650 | 10 | In distribution | |
| M01107 | 10 | In distribution | |
| M01133 | 10 | In distribution | |
| M01120 | 10 | In distribution | |
| A06528 | 10 | In distribution | |
| A06511 | 10 | In distribution | |
| M01652 | 10 | In distribution | |
| M01600 | 10 | In distribution | |
| KM01690 | 20 | In distribution | |
| M01106 | 10 | In distribution | |
| M01129 | 10 | In distribution | |
| M01161 | 10 | In distribution | |
| M01679 | 10 | In distribution | |
| A06530 | 10 | In distribution | |
| M01124 | 10 | In distribution | |
| M01103 | 10 | In distribution | |
| M01139 | 10 | In distribution | |
| KM01680 | 20 | In distribution | |
| M01102 | 10 | In distribution | |
| M01628 | 10 | In distribution | |
| A06533 | 10 | In distribution | |
| M01160 | 10 | In distribution | |
| M01694 | 10 | In distribution | |
| KM01601 | 20 | In distribution | |
| M01111 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Leone SPA | Leone SPA | 2,306 |
| BioQuick® | Forestadent Bernhard Förster GmbH | 1,842 |
| Mini Master Series | American Orthodontics | 1,505 |
| Mini-Mono® | Forestadent Bernhard Förster GmbH | 1,225 |
| LP Low Profile | American Orthodontics | 1,204 |
| Mini Sprint® | Forestadent Bernhard Förster GmbH | 1,193 |
| Empower Bracket | American Orthodontics | 1,175 |
| Legend | GC Orthodontics America Inc. | 1,098 |
| Master Series | American Orthodontics | 1,084 |
| Experience® | GC Orthodontics America Inc. | 770 |
| The Orthodontic Store | Young Innovations Inc. | 658 |
| equilibrium® | Dentaurum GmbH & Co. KG | 646 |
Showing 12 of 876. All products under Bracket, Metal, Orthodontic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K902050 | 1990-08-03 |
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.