Iris
4 catalogue numbers from 4391-035, listed by Benco Dental Supply Co., under Probe, Periodontic. 34 manufacturers in China are registered for this product code.
34manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (6), Hebei (5). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Anqing Kangmingna Packaging Co., Ltd. | Anqing | Anhui | Contract manufacturer | 39 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Amedcon Medical Technology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| 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 |
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | Heze | Shandong | Contract manufacturer | 65 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
Showing 12 of 34. All 34 manufacturers in China registered for Probe, Periodontic
Record
| Listed by | Benco Dental Supply Co. |
|---|---|
| FDA product code | EIX |
| Device type | Probe, Periodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2022-08-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4391-035 | In distribution | |
| 4391-026 | In distribution | |
| 4390-992 | In distribution | |
| 4391-044 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 354 |
| Surgical Direct | Surgical Direct, Inc. | 195 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 143 |
| American Eagle Instruments | American Eagle Instruments | 127 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 74 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 61 |
| Power Dental USA | Power Dental U.S.A. Inc. | 57 |
| Osung MND | Osung MND Co., Ltd. | 52 |
| Premier Probes | Premier Dental Products Co. | 52 |
| Pomee | Pomee Corporation | 51 |
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 41 |
| Henry Schein | Henry Schein, Inc. | 38 |
Showing 12 of 64. All products under Probe, Periodontic
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.