Darby Dental Supply, LLC
Take Home Whitening KT12%HP(3)
33manufacturers in China registered for this device type
13catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (15), Jiangsu (5), Jiangxi (4). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Nanchang White Technology Co., Ltd. | Nanchang | Jiangxi | Contract manufacturer | 21 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | Heze | Shandong | Contract manufacturer | 65 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
| Guangdong Xinuo Personal Care Products Co., Ltd. | Yunfu | Guangdong | Manufacturer | 33 |
| Shenzhen Senlede Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 33 |
| Shenzhen Balinda Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 23 |
| BUY Asia Enterprise Ltd | Dongguan | Guangdong | Private-label distributor | 22 |
| Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | Zhengzhou | Henan | Contract manufacturer | 21 |
| Llrn Personal Care (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 20 |
| Ekong Technology Co., Limited | Shenzhen | Guangdong | Manufacturer | 19 |
| Huizhou Gold Rose Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 19 |
Showing 12 of 33. All 33 manufacturers in China registered for Eraser, Dental Stain
Record
| Listed by | Darby Dental Supply, LLC |
|---|---|
| FDA product code | MAU |
| Device type | Eraser, Dental Stain |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6855 |
| Premarket notification | Exempt |
| Record published | 2022-07-18 |
| Record revised | 2025-11-20 (version 2) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9430212 | 50 | In distribution | |
| 9430211 | 50 | In distribution | |
| 9430209 | In distribution | ||
| 9430210 | 50 | In distribution | |
| 9430208 | In distribution | ||
| 9430200 | In distribution | ||
| 9430203 | 50 | In distribution | |
| 9430201 | In distribution | ||
| 9430207 | In distribution | ||
| 9430202 | In distribution | ||
| 9430206 | In distribution | ||
| 9430204 | 50 | In distribution | |
| 9430205 | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GlorySmile | Jiangxi Dentalbright Technology Co., Ltd. | 28 |
| SmileSet Premium Whitening Sample Pen → 3 ml | Ortho Dental LAB, LLC | 1 |
| SmileSet Premium Whitening Refill → 4 Pack | Ortho Dental LAB, LLC | 1 |
| SmileDirectClub Dissolving Strips | Ortho Dental LAB, LLC | 1 |
| SmileDirectClub Whitening plus Lip Balm – 4 Pack | Ortho Dental LAB, LLC | 1 |
| Daniel | Jiangxi Dentalbright Technology Co., Ltd. | 1 |
| SmileSet Premium Whitening Kit → Black | Ortho Dental LAB, LLC | 1 |
| SmileSet Premium Whitening Kit → Mint | Ortho Dental LAB, LLC | 1 |
| SmileDirectClub Whitening Refill – 8 Pack | Ortho Dental LAB, LLC | 1 |
| Non | Jiangxi Dentalbright Technology Co., Ltd. | 1 |
| Dr.DENT.co | Jiangxi Dentalbright Technology Co., Ltd. | 1 |
| Senlede | Shenzhen Senlede Technologies Co., Ltd. | 1 |
Showing 12 of 18. All products under Eraser, Dental Stain
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.