Invisalign UV Sanitizing Case
The Invisalign UV Sanitizing Case is a portable, over-the-counter device that is intended to sanitize Invisalign clear aligners.
25manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (15), Zhejiang (3), Shanghai (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Bandex Industrial Corp. | Zhuhai | Guangdong | Contract manufacturer | 14 |
| Shenzhen Heearly Technology Co., Ltd. | Bao An District, Shenzhen | Guangdong | Contract manufacturer | 13 |
| Hayco Industries (Shenzhen) Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Xiamen Atyou Health Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 2 |
| Shenzhen Balinda Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 23 |
| Unisource Shanghai Ltd. | Shanghai | Shanghai | Reprocessor | 23 |
| Wenzhou Zuoyou Medical Technoloyg Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 21 |
| Jiangxi Ivismile Technology Co., Ltd. | Yichun | Jiangxi | Manufacturer | 18 |
| Ningbo Cooskin Stationery Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 18 |
| Dongguan Yingfeng Metal & Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Shenzhen Relish Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Shenzhen Samo Technology Co., Limited | Shenzhen | Guangdong | Manufacturer | 9 |
Showing 12 of 25. All 25 manufacturers in China registered for Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile
Record
| Listed by | Align Technology, Inc., United States |
|---|---|
| FDA product code | NOB |
| Device type | Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6855 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-07-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 214150 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SmileSet QX105 Ultrasonic Cleaner – White | Ortho Dental LAB, LLC | 1 |
| Smileset Rechargeable Ultrasonic Cleaner → Mint | Ortho Dental LAB, LLC | 1 |
| SmileSet QX105 Ultrasonic Cleaner – Black | Ortho Dental LAB, LLC | 1 |
| Smileset Rechargeable Ultrasonic Cleaner → White | Ortho Dental LAB, LLC | 1 |
| Portable UV Sanitizer | Straight Smile, LLC | 1 |
| SmileSet Rechargeable Ultrasonic Cleaner – Black | Ortho Dental LAB, LLC | 1 |
| Philips Sonicare | Philips Oral Healthcare, LLC | 1 |
| The Orthodontic Store | Young Innovations Inc. | 1 |
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.