DCI Edge
Series 5 Dental Chair with 200 Watt Transformer and AirSoothe
38manufacturers in China registered for this device type
10catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (9), Guangdong (8), Shanghai (7). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Hefei Xingcheng Sanitary Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 21 |
| Yongqing Huaguan Dental Instruments Factory | Langfang | Hebei | Contract manufacturer | 9 |
| Shanghai Greeloy Industry Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 9 |
| A.R. Medicom Inc. (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Changzhou Shengjie Medical Product Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd. | Qianjiang | Hubei | Contract manufacturer | 52 |
| TF NEW Material SCI AND TEC Co., Ltd. | Huainan | Anhui | Manufacturer | 51 |
Showing 12 of 38. All 38 manufacturers in China registered for Chair, Dental, Without Operative Unit
Record
| Listed by | DCI International, LLC, United States |
|---|---|
| FDA product code | NRU |
| Device type | Chair, Dental, Without Operative Unit |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6250 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-08-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C5052 | In distribution | |
| C5152 | In distribution | |
| C5552 | In distribution | |
| C4152 | In distribution | |
| C5551 | In distribution | |
| C4052 | In distribution | |
| C4550 | In distribution | |
| C1050 | In distribution | |
| C5550 | In distribution | |
| C4551 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Henry Schein | Henry Schein, Inc. | 31 |
| A-dec | A-dec, Inc. | 30 |
| Palmero Healthcare, LLC | Palmero Healthcare LLC | 25 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 19 |
| iSmile | Ismile Dental Products Inc. | 18 |
| Forest | Ls Enterprises, Inc. | 18 |
| Unipack | Unipack LLC | 16 |
| Midmark | Midmark Corporation | 13 |
| MTI | Tech Industries. Inc. | 9 |
| Defend | Young Innovations Inc. | 9 |
| Aseptico | Aseptico, Inc. | 9 |
| Medicom Safebasics | AMD Medicom Inc. | 8 |
Showing 12 of 60. All products under Chair, Dental, Without Operative Unit
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-03-01 | Not classified | Process control | Link arm assembly that mounts the rear mounted accessories to the dental chair may potentially break and fall off the dental chair. | 55 chairs and 11 replacement bolts distributed to US and for | 2011-09-21 |
| 2010-03-23 | Not classified | Other | The magnetic headrest on certain dental chairs may affect the function/programming of some implantable pacemakers or defibrillators if the implanted device is programmed to respond to a magnet. | 108 | 2012-01-04 |
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.