SureSmile®
SureSmile Aligner Starter Kit (Doctor Kit)
18manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (7), Zhejiang (2), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Henan Baistra Medical Devices Limited | Zhengzhou | Henan | Manufacturer | 34 |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan | Hebei | Manufacturer | 34 |
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Unisource Shanghai Ltd. | Shanghai | Shanghai | Reprocessor | 23 |
| Llrn Personal Care (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 20 |
| Guangxi Ehall Medical Technology Co., Ltd. | Nanning | Guangxi | Manufacturer | 17 |
| Changsha Easyinsmile Intelligence Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 15 |
Showing 12 of 18. All 18 manufacturers in China registered for Strip, Polishing Agent
Record
| Listed by | Dentsply Sirona Orthodontics Inc., United States |
|---|---|
| FDA product code | EHM |
| Device type | Strip, Polishing Agent |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6010 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-05-01 |
| Record revised | 2023-11-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| ORX00006 | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sunshine Diamonds | DR. Hopf Gmbh & Co. KG | 197 |
| Horico | Hopf, Ringleb & Co. Gmbh & CIE. | 146 |
| MDT Diamond Coated Dental Flexible Strips | M.D.T. – Micro Diamond Technologies Ltd. | 121 |
| ContacEZ | Directa AB | 104 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 95 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 77 |
| Galaxy™ | Ortho Organizers, Inc. | 47 |
| NEW Metal Strips | GC America Inc. | 34 |
| SpaceFile® | Dentsply Sirona Orthodontics Inc. | 29 |
| Microdont | 3R – Industria E Comercio Eireli | 28 |
| Two Striper | Abrasive Technology, LLC | 21 |
| Denfinity | 3R – Industria E Comercio Eireli | 21 |
Showing 12 of 83. All products under Strip, Polishing Agent
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.