Integra
INT Roth MN CUS 18R 7A -11T HK 2MO
52manufacturers in China registered for this device type
75catalogue 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 | 2024-08-27 |
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 |
|---|---|---|---|
| M09108 | 10 | In distribution | |
| M09133 | 10 | In distribution | |
| M09227 | 10 | In distribution | |
| KM09202 | 20 | In distribution | |
| M09202 | 10 | In distribution | |
| M09124 | 10 | In distribution | |
| M09325 | 10 | In distribution | |
| M09107 | 10 | In distribution | |
| M09301 | 10 | In distribution | |
| M09109 | 10 | In distribution | |
| M09203 | 10 | In distribution | |
| M09211 | 10 | In distribution | |
| M09223 | 10 | In distribution | |
| M09111 | 10 | In distribution | |
| M09302 | 10 | In distribution | |
| M09130 | 10 | In distribution | |
| M09200 | 10 | In distribution | |
| M09122 | 10 | In distribution | |
| M09126 | 10 | In distribution | |
| M09207 | 10 | In distribution | |
| KM09102 | 20 | In distribution | |
| M09104 | 10 | In distribution | |
| M09226 | 10 | In distribution | |
| M09231 | 10 | In distribution | |
| M09125 | 10 | In distribution | |
| M09131 | 10 | In distribution | |
| M09132 | 10 | In distribution | |
| M09307 | 10 | In distribution | |
| M09103 | 10 | In distribution | |
| M09324 | 10 | In distribution | |
| M09222 | 10 | In distribution | |
| KM09201 | 20 | In distribution | |
| M09229 | 10 | In distribution | |
| KM09301 | 20 | In distribution | |
| M09327 | 10 | In distribution | |
| M09224 | 10 | In distribution | |
| M09102 | 10 | In distribution | |
| M09306 | 10 | In distribution | |
| M09303 | 10 | In distribution | |
| M09209 | 10 | In distribution | |
| M09123 | 10 | In distribution | |
| M09205 | 10 | In distribution | |
| M09106 | 10 | In distribution | |
| KM09302 | 20 | In distribution | |
| M09204 | 10 | In distribution | |
| M09304 | 10 | In distribution | |
| M09225 | 10 | In distribution | |
| M09101 | 10 | In distribution | |
| M09233 | 10 | In distribution | |
| M09220 | 10 | In distribution | |
| M09326 | 10 | In distribution | |
| M09128 | 10 | In distribution | |
| M09232 | 10 | In distribution | |
| KM09200 | 20 | In distribution | |
| M09208 | 10 | In distribution | |
| M09230 | 10 | In distribution | |
| KM09101 | 20 | In distribution | |
| M09206 | 10 | In distribution | |
| M09320 | 10 | In distribution | |
| M09110 | 10 | In distribution | |
| M09100 | 10 | In distribution | |
| M09201 | 10 | In distribution | |
| M09120 | 10 | In distribution | |
| M09127 | 10 | In distribution | |
| M09300 | 10 | In distribution | |
| KM09300 | 20 | In distribution | |
| M09228 | 10 | In distribution | |
| M09210 | 10 | In distribution | |
| M09129 | 10 | In distribution | |
| M09308 | 10 | In distribution | |
| M09105 | 10 | In distribution | |
| M09310 | 10 | In distribution | |
| M09305 | 10 | In distribution | |
| KM09100 | 20 | In distribution | |
| M09311 | 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.