Biolon
38 catalogue numbers from D420008, listed by Dreve Dentamid Gmbh, Germany, under Positioner, Tooth, Preformed. 19 manufacturers in China are registered for this product code.
19manufacturers in China registered for this device type
38catalogue 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 | Dreve Dentamid Gmbh, Germany |
|---|---|
| FDA product code | KMY |
| Device type | Positioner, Tooth, Preformed |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5525 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-08-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 18 to 28 °C; Special storage condition: Keep dry |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D420008 | In distribution | |
| D420006Q | In distribution | |
| D420012SQ | In distribution | |
| D420023 | In distribution | |
| D420006S | In distribution | |
| D420020 | In distribution | |
| D420022 | In distribution | |
| D420021 | In distribution | |
| D420010 | In distribution | |
| D420004S | In distribution | |
| D420011 | In distribution | |
| D420002SQ | In distribution | |
| D420010SQ | In distribution | |
| D420006SQ | In distribution | |
| D420004SQ | In distribution | |
| D420007 | In distribution | |
| D420024 | In distribution | |
| D420006SP | In distribution | |
| D420002 | In distribution | |
| D420004Q | In distribution | |
| D420012 | In distribution | |
| D420010Q | In distribution | |
| D420006 | In distribution | |
| D420008S | In distribution | |
| D420004 | In distribution | |
| D420005 | In distribution | |
| D420012S | In distribution | |
| D420020SP | In distribution | |
| D420008Q | In distribution | |
| D420002SP | In distribution | |
| D420010S | In distribution | |
| D420004SP | In distribution | |
| D420003 | In distribution | |
| D420019 | In distribution | |
| D420001 | In distribution | |
| D420009 | In distribution | |
| D420020S | In distribution | |
| D420002S | 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 |
| Positioner, Tooth, Preformed | Dentaurum GmbH & Co. KG | 31 |
| The Trainer System™ | Myofunctional Research Corp. PTY. Ltd. | 30 |
| IPS | KLS-Martin L.P. | 28 |
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.