Lower ROC Pack for Herbst LR5 10mm
Catalogue number 900657, listed by Specialty Appliances, LLC, United States, under Clamp, Wire, Orthodontic. 27 manufacturers in China are registered for this product code.
27manufacturers in China registered for this device type
1catalogue number
10recalls on this code
Who Else Makes It
Concentrated in Zhejiang (13), Jiangsu (5), Guangdong (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | Yang Jiao Lang Zin’An Town | Zhejiang | Manufacturer | 39 |
| Henan Baistra Medical Devices Limited | Zhengzhou | Henan | Manufacturer | 34 |
| Huizhou Videya Technology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 18 |
| Changsha Nice Medical Instrument Limited Company | Changsha | Hunan | Manufacturer | 17 |
| Orthguide Medical Technology (Jiangsu) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 17 |
| Zhejiang Protect Medical Equipment Co., Ltd. | Anji | Zhejiang | Manufacturer | 16 |
| Guangzhou Cheer-U Material Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 15 |
Showing 12 of 27. All 27 manufacturers in China registered for Clamp, Wire, Orthodontic
Record
| Listed by | Specialty Appliances, LLC, United States |
|---|---|
| FDA product code | ECN |
| Device type | Clamp, Wire, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-10-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 900657 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 3M™ Unitek™ | 3M Unitek | 58 |
| Lingual Sheaths | American Orthodontics | 36 |
| Crimpable Stop | American Orthodontics | 29 |
| Arch Hook | American Orthodontics | 26 |
| JMU | JMU Dental, Inc | 25 |
| Clamp, Wire, Orthodontic | Dentaurum GmbH & Co. KG | 24 |
| OSE | Orthodontic Supply & Equipment Co., Inc. | 22 |
| Buttons | American Orthodontics | 22 |
| Morelli | Dental Morelli Ltda. | 21 |
| Arch Lock | American Orthodontics | 19 |
| ORJ | Fortune Worldwide LLC | 18 |
| The Orthodontic Store | Young Innovations Inc. | 17 |
Showing 12 of 405. All products under Clamp, Wire, Orthodontic
Recalls
10 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-03-09 | Class II | Under Investigation by firm | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | 14,428 Universal Nuts | 2017-01-12 |
| 2015-03-09 | Class II | Under Investigation by firm | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | 14,428 Universal Nuts | 2017-01-12 |
| 2015-03-09 | Class II | Under Investigation by firm | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | 14,428 Universal Nuts | 2017-01-12 |
| 2015-03-09 | Class II | Under Investigation by firm | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | 14,428 Universal Nuts | 2017-01-12 |
| 2015-03-09 | Class II | Under Investigation by firm | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | 14,428 Universal Nuts | 2017-01-12 |
| 2015-03-09 | Class II | Under Investigation by firm | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | 14,428 Universal Nuts | 2017-01-12 |
| 2015-03-09 | Class II | Under Investigation by firm | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | 14,428 Universal Nuts | 2017-01-12 |
| 2015-03-09 | Class II | Under Investigation by firm | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | 14,428 Universal Nuts | 2017-01-12 |
| 2015-03-09 | Class II | Under Investigation by firm | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | 14,428 Universal Nuts | 2017-01-12 |
| 2015-03-09 | Class II | Under Investigation by firm | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | 14,428 Universal Nuts | 2017-01-12 |
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.