A-Dec
A-dec 363BR Pedestal MT Support System Certified Pre-Owned
23manufacturers in China registered for this device type
12catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (9), Jiangsu (8), Shanghai (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| Shanghai Greeloy Industry Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 9 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 33 |
| Shanghai NO. 2 Medical College Duhang Medical Equipment Factory | Shanghai | Shanghai | Contract manufacturer | 32 |
| Jiangsu Rooe Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 31 |
Showing 12 of 23. All 23 manufacturers in China registered for Unit, Suction Operatory
Record
| Listed by | A-dec, Inc., United States |
|---|---|
| FDA product code | EBR |
| Device type | Unit, Suction Operatory |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6640 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-03-27 |
| Record revised | 2023-06-07 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2023-06-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 461R | In distribution | |
| 363 | In distribution | |
| 300AVS | In distribution | |
| 362R | In distribution | |
| 200AVS | In distribution | |
| 363R | In distribution | |
| 461 | In distribution | |
| 200SUA | In distribution | |
| 561R | In distribution | |
| 362 | In distribution | |
| 561 | Withdrawn | |
| 8200B | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ACE | Ace Surgical Supply Co., Inc. | 33 |
| Isolite, i3 | Zyris, Inc. | 24 |
| Isovac, Connector | Zyris, Inc. | 9 |
| Aesculap | Aesculap AG | 8 |
| Isodry | Zyris, Inc. | 7 |
| Hygitech | Hygitech | 7 |
| Isovac | Zyris, Inc. | 6 |
| Kohdent | Kohler Medizintechnik GmbH | 5 |
| Isolite, i2 | Zyris, Inc. | 3 |
| Maquira | Maquira Industria de Produtos Odontologicos S/A | 3 |
| Accessories | Zyris, Inc. | 3 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 2 |
Showing 12 of 37. All products under Unit, Suction Operatory
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K925367 | 1994-04-11 |
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.