MyoSimple
2 catalogue numbers from MyoSimple Small Size, listed by Biotech Dental Smilers, SAS, France, under Positioner, Tooth, Preformed. 19 manufacturers in China are registered for this product code.
19manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (6), Guangdong (6), Shanghai (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Sezen Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | Yang Jiao Lang Zin’An Town | Zhejiang | Manufacturer | 39 |
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Nanchang White Technology Co., Ltd. | Nanchang | Jiangxi | Contract manufacturer | 21 |
| Huizhou Gold Rose Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 19 |
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Royal Dental Lab | Shenzhen | Guangdong | Manufacturer | 12 |
| Hubei YJT Intelligent Technology Group Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 12 |
Showing 12 of 19. All 19 manufacturers in China registered for Positioner, Tooth, Preformed
Record
| Listed by | Biotech Dental Smilers, SAS, France |
|---|---|
| FDA product code | KMY |
| Device type | Positioner, Tooth, Preformed |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5525 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-03-26 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature 5 to 40 °C; Special storage condition: Keep away from heat, sunlight, and sources of radiation. |
| Sizes | Length 62.94 mm; width 22.2 mm; height 41.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MyoSimple Small Size | In distribution | |
| MyoSimple Standard Size | Length 62.94 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Amcop Bioactivator | Micerium SPA | 265 |
| LMDental | LM-Dental | 195 |
| Myobrace® | Myofunctional Research Corp. PTY. Ltd. | 123 |
| Pre-Finisher | TP Orthodontics, Inc. | 120 |
| Drufosoft® | Dreve Dentamid Gmbh | 93 |
| Proform | Keystone Industries | 88 |
| Orthocryl® | Dentaurum GmbH & Co. KG | 65 |
| Atmos | American Orthodontics | 45 |
| Duran® | Scheu-Dental Gmbh | 40 |
| Biolon | Dreve Dentamid Gmbh | 38 |
| Positioner, Tooth, Preformed | Dentaurum GmbH & Co. KG | 31 |
| The Trainer System™ | Myofunctional Research Corp. PTY. Ltd. | 30 |
Showing 12 of 220. All products under Positioner, Tooth, Preformed
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.