STb
UP/LO 4 and 5 UNIV STb LIGHT LINGUAL 18 11/0/0 HK
52manufacturers in China registered for this device type
30catalogue numbers in this listing
8510(k) clearances naming this product code
2recalls on this code
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 | Ormco Corporation, United States |
|---|---|
| FDA product code | EJF |
| Device type | Bracket, Metal, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 369-3701 | Slot size 018, Torque 10, Angulation 5, Distal Offset 5 | 10 | In distribution |
| 369-2102 | Slot size 018, Torque 55, Angulation 0, Distal Offset 0 | 10 | In distribution |
| 369-3600 | Slot size 018, Torque 10, Angulation 5, Distal Offset 5 | 10 | In distribution |
| 369-3400 | Slot size 018, Torque 11, Angulation 0, Distal Offset 0 | 10 | In distribution |
| 740-0424 | Slot size 018 inches | In distribution | |
| 369-3601 | Slot size 018, Torque 10, Angulation 5, Distal Offset 5 | 10 | In distribution |
| 740-0416 | Slot size 018, Torque 55, Angulation 0, Rotation 0 | 6 | In distribution |
| 740-0411 | Slot size 018 inches | In distribution | |
| 369-3403 | Slot size 018, Torque 0, Angulation 0, Distal Offset 0 | 10 | In distribution |
| 369-2401 | Slot size 018, Torque 0, Angulation 0, Distal Offset 0 | 10 | In distribution |
| 369-3102 | Slot size 018, Torque 55, Angulation 0 | 10 | In distribution |
| 369-3610 | Slot size 018, Torque 0, Angulation 0, Distal Offset 0 | 10 | In distribution |
| 369-3401 | Slot size 018, Torque 0, Angulation 0 | 10 | In distribution |
| 740-0417 | Slot size 018 inches | In distribution | |
| 369-2403 | Slot size 018, Torque 0, Angulation 0, Distal Offset 0 | 10 | In distribution |
| 369-2402 | Slot size 018, Torque 11, Angulation 0, Distal Offset 0 | 10 | In distribution |
| 740-0421 | Slot size 018 inches | In distribution | |
| 740-0415 | Slot size 018 inches | In distribution | |
| 740-0422 | Slot size 018 inches | In distribution | |
| 740-0425 | Slot size 018 inches | In distribution | |
| 369-3402 | Slot size 018, Torque 11, Angulation 0 | 10 | In distribution |
| 740-0412 | Slot size 018 inches | In distribution | |
| 369-3110 | Slot size 018, Torque 40, Angulation 0, Distal Offset 0 | 10 | In distribution |
| 369-3700 | Slot size 018, Torque 10, Angulation 5, Distal Offset 5 | 10 | In distribution |
| 369-3611 | Slot size 018, Torque 0, Angulation 0 | 10 | In distribution |
| 369-3711 | Slot size 018, Torque 0, Angulation 0, Distal Offset 0 | 10 | In distribution |
| 740-0414 | Slot size 018 inches | In distribution | |
| 369-2110 | Slot size 018, Torque 40, Angulation 0, Distal Offset 0 | 10 | In distribution |
| 369-2400 | Slot size 018, Torque 11, Angulation 0, Distal Offset 0 | 10 | In distribution |
| 369-3710 | Slot size 018, Torque 0, Angulation 0, Distal Offset 0 | 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 |
|---|---|
| K922806 | 1993-10-20 |
| K923405 | 1993-05-05 |
| K914616 | 1991-11-20 |
| K900184 | 1990-04-02 |
| K894358 | 1989-09-15 |
| K894781 | 1989-09-15 |
| K892704 | 1989-06-12 |
| K870536 | 1987-02-19 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-02-13 | Not classified | Process control | The recall was initiated because Ormco has confirmed that manufacturing error resulted in the Orthos CM Brackets being incorrectly manufactured with a torque of -9. The packaging was labeled with +9 torque; however the brackets contained in | 304 units | 2012-03-02 |
| 2004-11-18 | Not classified | Other | Misassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed. | 6,257 | 2005-06-17 |
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.