ProBarrier
Environmental surface barrier, 29" x 30" Instrument/equipment drape chair sox
4manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Dynamic Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 12 |
| Foshan Gladent Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 6 |
| Guangdong Yadeng Medical Apparatus Co., Ltd. | Foshan | Guangdong | Manufacturer | 2 |
| Mipont Medical Equipment Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 2 |
Record
| Listed by | MicroCare Medical, United States |
|---|---|
| FDA product code | KLC |
| Device type | Chair, Dental, With Operative Unit |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6250 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K922175 |
| Record published | 2022-10-26 |
| Record revised | 2024-09-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
| Packaging | Case box of 10, case box of 6, pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DC-0115S | 300 | In distribution | |
| BB-0528X | 250 | In distribution | |
| BB-0312H | 500 | In distribution | |
| BB-2930C | 200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Barrier | Certol International, LLC | 4 |
| Planmeca Chair | Planmeca Oy | 1 |
| Luvis Chair (LC700C) | Dentis Co., Ltd. | 1 |
| Dental Chair | Alliage S/A Indústrias Médico Odontológica | 1 |
| DCI Edge | DCI International, LLC | 1 |
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.