BlueSkiBio
The AEU-1000BSB-70V dental Implant Motor System with variable-speed footswitch Blue Sky Bio is a drive system for instruments and tools used in dentistry for implant procedures.
10manufacturers in China registered for this device type
1catalogue number
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (2), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jung Chen Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 2 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Denjoy Dental Co., Ltd. | Changsha | Hunan | Contract manufacturer | 17 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Shenzhen Superline Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 12 |
| Shenzhen Perfect Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 10 |
| Changzhou Bomedent Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
Record
| Listed by | Aseptico, Inc., United States |
|---|---|
| FDA product code | EKX |
| Device type | Handpiece, Direct Drive, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4200 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2022-07-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment humidity 10 to 90 % RH; Handling environment temperature 10 to 28 °C |
| Distribution end date | 2032-07-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AEU-1000BSB-70V | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MulTipeg™ | Integration Diagnostics Sweden AB | 151 |
| Aseptico | Aseptico, Inc. | 40 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 26 |
| Woodpecker | Guilin Woodpecker Medical Instrument Co., Ltd. | 16 |
| DTE | Guilin Woodpecker Medical Instrument Co., Ltd. | 16 |
| Delfin2 | Intra-Lock International | 16 |
| Ultrapro TX Cordless | Ultradent Products Inc. | 13 |
| CanalPro | Coltene/Whaledent Gmbh & Co. KG | 12 |
| ChecQPEG | Dentis Co., Ltd. | 12 |
| EdgeApex HP™ | US Endodontics, LLC | 11 |
| Penguin RFA | Integration Diagnostics Sweden AB | 10 |
| Henry Schein | Henry Schein, Inc. | 9 |
Showing 12 of 307. All products under Handpiece, Direct Drive, Ac-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150129 | 2015-05-28 |
| K142124 | 2014-12-31 |
| K111078 | 2011-06-14 |
| K103399 | 2011-02-28 |
| K030163 | 2003-03-03 |
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.