SmileDirectClub Dissolving Strips
Catalogue number 130-0101, listed by Ortho Dental LAB, LLC, United States, under Eraser, Dental Stain. 33 manufacturers in China are registered for this product code.
33manufacturers in China registered for this device type
1catalogue number
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 | Ortho Dental LAB, LLC, United States |
|---|---|
| FDA product code | MAU |
| Device type | Eraser, Dental Stain |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6855 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-10-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 130-0101 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GlorySmile | Jiangxi Dentalbright Technology Co., Ltd. | 28 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 13 |
| SmileSet Premium Whitening Sample Pen → 3 ml | Ortho Dental LAB, LLC | 1 |
| SmileSet Premium Whitening Refill → 4 Pack | 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.