Amcop Bioactivator
Amcop Bioactivator AMCOP BIOACTIVATOR HARD Class I Mod. S Integral Size 4 - 65 mm
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 | Micerium SPA |
|---|---|
| FDA product code | KMY |
| Device type | Positioner, Tooth, Preformed |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5525 |
| Premarket notification | Exempt |
| Record published | 2025-03-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BSC1-DCMH | In distribution | |
| BIO-BS4HM | In distribution | |
| BIO-0S5M | In distribution | |
| BIO-SC3HM | In distribution | |
| B0S1-DTMH | In distribution | |
| BS4-DTMH | In distribution | |
| BS2-DTMH | In distribution | |
| B0S2-DCMH | In distribution | |
| BTC2-DCM | In distribution | |
| BC1-DTM | In distribution | |
| BIO-OPEN4M | In distribution | |
| BIO-0S1M | In distribution | |
| BIO-SC1HM | In distribution | |
| BIO-S5HM | In distribution | |
| BIO-F4M | In distribution | |
| BS4-DCMH | In distribution | |
| BC1-DTMH | In distribution | |
| B0S4-DEEPH | In distribution | |
| B0S3-DTMH | In distribution | |
| BIO-B0S5HM | In distribution | |
| BIO-0S2HM | In distribution | |
| BS2-DCMH | In distribution | |
| BS5-DTM | In distribution | |
| BSC4-DTMH | In distribution | |
| B0S2-DEEPH | In distribution | |
| BF2-DCM | In distribution | |
| BIO-OPEN5M | In distribution | |
| BSC3-DTM | In distribution | |
| BIO-OPEN1M | In distribution | |
| BC5-DEEPH | In distribution | |
| BC1-DEEPH | In distribution | |
| B0S3-DCM | In distribution | |
| BIO-SC3M | In distribution | |
| BTC2-DTM | In distribution | |
| B0S5-DTMH | In distribution | |
| B0S2-DTM | In distribution | |
| BS4-DEEP | In distribution | |
| BF4-DEEP | In distribution | |
| B0S2-DEEP | In distribution | |
| BIO-SC2HM | In distribution | |
| BIO-F3HM | In distribution | |
| BS4-DTM | In distribution | |
| BIO-B0S1M | In distribution | |
| BSC3-DTMH | In distribution | |
| BTC3-DTM | In distribution | |
| BIO-TC2M | In distribution | |
| BIO-S4HM | In distribution | |
| B0S1-DTM | In distribution | |
| BIO-B0S3M | In distribution | |
| BIO-B0S4M | In distribution | |
| BC5-DCMH | In distribution | |
| BIO-BF3M | In distribution | |
| BTC3-DCMH | In distribution | |
| BS5-DEEPH | In distribution | |
| BIO-BC4HM | In distribution | |
| BSC4-DCMH | In distribution | |
| BTC2-DTMH | In distribution | |
| BIO-BF4HM | In distribution | |
| BSC5-DCMH | In distribution | |
| BIO-F2M | In distribution | |
| BC3DTMH | In distribution | |
| BF3-DEEPH | In distribution | |
| BS3-DTM | In distribution | |
| BF5-DTM | In distribution | |
| BIO-BS2M | In distribution | |
| BC5-DEEP | In distribution | |
| BIOB0S2HM | In distribution | |
| BC4-DCM | In distribution | |
| BIO-BC5M | In distribution | |
| BF1-DCMH | In distribution | |
| BTC2-DCMH | In distribution | |
| BS5-DCMH | In distribution | |
| BIO-F3M | In distribution | |
| BC5-DTMH | In distribution | |
| BSC3-DCMH | In distribution | |
| BIO-BS3HM | In distribution | |
| BSC4-DTM | In distribution | |
| BSC2-DCM | In distribution | |
| BF1-DEEP | In distribution | |
| BC2-DCM | In distribution | |
| BF4-DEEPH | In distribution | |
| B0S2-DCM | In distribution | |
| BF4-DCM | In distribution | |
| BSC1-DTMH | In distribution | |
| BIO-C5HM | In distribution | |
| BF2-DEEPH | In distribution | |
| BF3-DTMH | In distribution | |
| BIO-BF5M | In distribution | |
| BIO-S1M | In distribution | |
| BIO-IP5M | In distribution | |
| BIO-S2M | In distribution | |
| BF3-DCM | In distribution | |
| B0S4-DCM | In distribution | |
| BSC2-DTM | In distribution | |
| B0S3-DEEPH | In distribution | |
| BTC5-DCMH | In distribution | |
| BIO-DCR2M | In distribution | |
| BIO-BC4M | In distribution | |
| B0S5-DTM | In distribution | |
| BC3-DCM | In distribution | |
| BF3-DCMH | In distribution | |
| BIO-DR1M | In distribution | |
| BIO-SC5M | In distribution | |
| B0S4-DCMH | In distribution | |
| B0S4-DEEP | In distribution | |
| BIO-C3HM | In distribution | |
| BF4-DCMH | In distribution | |
| BIO-TC5HM | In distribution | |
| BS2-DCM | In distribution | |
| B0S5-DEEP | In distribution | |
| B0S4-DTM | In distribution | |
| BTC4-DTM | In distribution | |
| BIO-TC4M | In distribution | |
| BSC2-DTMH | In distribution | |
| BIO-0S3HM | In distribution | |
| BIO-C4M | In distribution | |
| BIO-BS2HM | In distribution | |
| BIO-DCA2M | In distribution | |
| BIO-0S2M | In distribution | |
| BS1-DCM | In distribution | |
| BS5-DTMH | In distribution | |
| BIO-BF5HM | In distribution | |
| BSC5-DTMH | In distribution | |
| BTC4-DTMH | In distribution | |
| B0S2-DTMH | In distribution | |
| BC3-DTM | In distribution | |
| BIO-S1HM | In distribution | |
| BTC5-DTM | In distribution | |
| BIO-OPEN3M | In distribution | |
| BS1-DEEPH | In distribution | |
| BS1-DEEP | In distribution | |
| BTC1-DTM | In distribution | |
| BIO-DA2HM | In distribution | |
| BF5-DEEP | In distribution | |
| BTC5-DTMH | In distribution | |
| B0S5-DCM | In distribution | |
| B0S5-DEEPH | In distribution | |
| BTC4-DCM | In distribution | |
| BIO-BC5HM | In distribution | |
| BIO-OPEN2M | In distribution | |
| BIO-DCR1M | In distribution | |
| BF5-DCMH | In distribution | |
| BF1-DTM | In distribution | |
| BIO-TC3M | In distribution | |
| BIO-0S4HM | In distribution | |
| BSC3-DCM | In distribution | |
| BSC2-DCMH | In distribution | |
| BF4-DTM | In distribution | |
| BIO-BS4M | In distribution | |
| BS3DTMH | In distribution | |
| B0S3-DTM | In distribution | |
| BF5-DCM | In distribution | |
| BF4-DTMH | In distribution | |
| BF2-DTM | In distribution | |
| BS5-DCM | In distribution | |
| BIO-SC2M | In distribution | |
| BIO-SC6M | In distribution | |
| BIO-BS3M | In distribution | |
| BIO-TC1HM | In distribution | |
| BTC1-DCM | In distribution | |
| BC2-DEEP | In distribution | |
| BIO-B0S5M | In distribution | |
| BIO-F5M | In distribution | |
| BF3-DEEP | In distribution | |
| BIO-F1M | In distribution | |
| BIO-TC1M | In distribution | |
| BTC1-DCMH | In distribution | |
| BC4-DEEPH | In distribution | |
| BIO-S4M | In distribution | |
| BIO-TC5M | In distribution | |
| BIO-0S4M | In distribution | |
| BS3-DCM | In distribution | |
| BF2-DCMH | In distribution | |
| BIO-DR2M | In distribution | |
| BS1-DTM | In distribution | |
| B0S1-DCMH | In distribution | |
| BIO-DA2M | In distribution | |
| BIO-S3M | In distribution | |
| BSC1-DCM | In distribution | |
| BIO-F4HM | In distribution | |
| BC2-DCMH | In distribution | |
| BIO-BC3M | In distribution | |
| BIO-S5M | In distribution | |
| BC2-DTM | In distribution | |
| BF1-DCM | In distribution | |
| BS1-DTMH | In distribution | |
| BIO-TC3HM | In distribution | |
| BIO-C1M | In distribution | |
| B0S1-DEEPH | In distribution | |
| BSC5-DCM | In distribution | |
| BIO-TC4HM | In distribution | |
| BF5-DEEPH | In distribution | |
| BS5-DEEP | In distribution | |
| BS1-DCMH | In distribution | |
| BIO-B0S4HM | In distribution | |
| BSC4-DCM | In distribution | |
| BTC5-DCM | In distribution | |
| BIO-BS5HM | In distribution | |
| BC2-DEEPH | In distribution | |
| B0S4-DTMH | In distribution | |
| BIO-C2HM | In distribution | |
| BIO-B0S2M | In distribution | |
| BIO-TC2HM | In distribution | |
| BIO-SC1M | In distribution | |
| BIO-BF3HM | In distribution | |
| BIO-C5M | In distribution | |
| BS4-DCM | In distribution | |
| BIO-0S1HM | In distribution | |
| BIO-BF4M | In distribution | |
| BSC5-DTM | In distribution | |
| BIO-BS1M | In distribution | |
| BS2-DEEPH | In distribution | |
| BIO-IP4M | In distribution | |
| BIO-C2M | In distribution | |
| BTC3-DTMH | In distribution | |
| BF3-DTM | In distribution | |
| BC1-DCM | In distribution | |
| BC2-DTMH | In distribution | |
| BC3-DEEPH | In distribution | |
| BC5-DTM | In distribution | |
| BSC1-DTM | In distribution | |
| BC3-DEEP | In distribution | |
| BC3DCMH | In distribution | |
| BTC3-DCM | In distribution | |
| BIO-BC3HM | In distribution | |
| BIO-BS5M | In distribution | |
| BC1-DCMH | In distribution | |
| BC4-DTM | In distribution | |
| BIO-SC5HM | In distribution | |
| BIO-F2HM | In distribution | |
| B0S3-DCMH | In distribution | |
| BC1-DEEP | In distribution | |
| BIO-C3M | In distribution | |
| BIO-DCA1M | In distribution | |
| BC4-DEEP | In distribution | |
| BTC1-DTMH | In distribution | |
| BIO-BS1HM | In distribution | |
| BIO-F5HM | In distribution | |
| BF1-DEEPH | In distribution | |
| BS4-DEEPH | In distribution | |
| B0S1-DEEP | In distribution | |
| B0S1-DCM | In distribution | |
| BS2-DTM | In distribution | |
| BIO-S3HM | In distribution | |
| BC5-DCM | In distribution | |
| BS3-DEEPH | In distribution | |
| BS3-DEEP | In distribution | |
| BIO-SC4HM | In distribution | |
| BC4-DTMH | In distribution | |
| BIO-C4HM | In distribution |
Showing 250 of 265 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.