Rumor
Rumor™ .022 Kit U/L 5x5 Roth HKS
52manufacturers in China registered for this device type
105catalogue numbers in this listing
2510(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 | Ortho Organizers, Inc., United States |
|---|---|
| FDA product code | EJF |
| Device type | Bracket, Metal, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K922499 |
| Record published | 2016-09-24 |
| Record revised | 2025-12-30 (version 6) |
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 |
| Distribution end date | 2020-07-06 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 306-0316-H-5 | In distribution | |
| 306-0401-5 | In distribution | |
| 306-2213-5 | In distribution | |
| 306-2212-H-5 | In distribution | |
| 306-0302-5 | In distribution | |
| 306-2214-H-5 | In distribution | |
| 306-2112-5 | In distribution | |
| 306-0406-5 | In distribution | |
| 306-2210-5 | In distribution | |
| 306-0312-5 | In distribution | |
| 306-2100-5 | In distribution | |
| 306-2206-5 | In distribution | |
| 306-2205-H-5 | In distribution | |
| 306-2115-5 | In distribution | |
| 306-2114-5 | In distribution | |
| 306-2106-H-5 | In distribution | |
| 306-2216-5 | In distribution | |
| 306-2215-H-5 | In distribution | |
| 306-0304-5 | In distribution | |
| 306-0316-5 | In distribution | |
| 306-0413-5 | In distribution | |
| 306-2113-5 | In distribution | |
| 306-0402-5 | In distribution | |
| 306-0300-5 | In distribution | |
| 306-0414-H-5 | In distribution | |
| 306-0410-5 | In distribution | |
| 306-2216-H-5 | In distribution | |
| 306-0415-5 | In distribution | |
| 306-2110-5 | In distribution | |
| 306-0407-5 | In distribution | |
| 306-0305-5 | In distribution | |
| 306-2202-5 | In distribution | |
| 306-2204-5 | In distribution | |
| 306-2223C | In distribution | |
| 306-2205-5 | In distribution | |
| 306-2207-5 | In distribution | |
| 306-0412-5 | In distribution | |
| 306-2200-5 | In distribution | |
| 306-2114-H-5 | In distribution | |
| 306-2215-5 | In distribution | |
| 306-2204-H-5 | In distribution | |
| 306-0406-H-5 | In distribution | |
| 306-0405-5 | In distribution | |
| 306-0306-5 | In distribution | |
| 306-0423C | In distribution | |
| 306-0307-5 | In distribution | |
| 306-0404-H-5 | In distribution | |
| 306-2105-H-5 | In distribution | |
| 306-0313-5 | In distribution | |
| 306-2214-5 | In distribution | |
| 306-0400-5 | In distribution | |
| 306-0314-H-5 | In distribution | |
| 306-2107-5 | In distribution | |
| 306-2213-H-5 | In distribution | |
| 306-2206-H-5 | In distribution | |
| 306-2101-5 | In distribution | |
| 306-2112-H-5 | In distribution | |
| 306-0413-H-5 | In distribution | |
| 306-2117-5 | In distribution | |
| 306-0315-H-5 | In distribution | |
| 306-0301-5 | In distribution | |
| 306-2102-5 | In distribution | |
| 306-0417-5 | In distribution | |
| 306-0416-H-5 | In distribution | |
| 306-0314-5 | In distribution | |
| 306-2104-5 | In distribution | |
| 306-2107-H-5 | In distribution | |
| 306-0305-H-5 | In distribution | |
| 306-0414-5 | In distribution | |
| 306-0405-H-5 | In distribution | |
| 306-0412-H-5 | In distribution | |
| 306-0415-H-5 | In distribution | |
| 306-2115-H-5 | In distribution | |
| 306-0323C | In distribution | |
| 306-0312-H-5 | In distribution | |
| 306-0322C | In distribution | |
| 306-2212-5 | In distribution | |
| 306-2116-H-5 | In distribution | |
| 306-0313-H-5 | In distribution | |
| 306-0407-H-5 | In distribution | |
| 306-2116-5 | In distribution | |
| 306-2117-H-5 | In distribution | |
| 306-0416-5 | In distribution | |
| 306-2203-5 | In distribution | |
| 306-0417-H-5 | In distribution | |
| 306-0315-5 | In distribution | |
| 306-0310-5 | In distribution | |
| 306-2222C | In distribution | |
| 306-2104-H-5 | In distribution | |
| 306-0306-H-5 | In distribution | |
| 306-2106-5 | In distribution | |
| 306-0307-H-5 | In distribution | |
| 306-0317-5 | In distribution | |
| 306-0303-5 | In distribution | |
| 306-0317-H-5 | In distribution | |
| 306-2113-H-5 | In distribution | |
| 306-2207-H-5 | In distribution | |
| 306-0304-H-5 | In distribution | |
| 306-2103-5 | In distribution | |
| 306-2201-5 | In distribution | |
| 306-0404-5 | In distribution | |
| 306-0403-5 | In distribution | |
| 306-2105-5 | In distribution | |
| 306-2217-H-5 | Withdrawn | |
| 306-2217-5 | Withdrawn |
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 |
|---|---|
| K923218 | 1993-09-13 |
| K931663 | 1993-07-08 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ultradent Products Inc. | 510(k) number | 2013-02-08 | Class III | Packaging | Orthodontic brackets distributed was incorrectly labeled. | 124 | 2013-06-07 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2019-04-02 | Class II | Process control | Orthodontic Bracket is mislabeled | 104 packages | 2022-03-24 |
| 2019-04-02 | Class II | Process control | Orthodontic Bracket is mislabeled | 147 kits | 2022-03-24 |
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.