Brasseler USA
GTEXC2 Gran Tissue Excavator 1P
34manufacturers in China registered for this device type
28catalogue 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 | Peter Brasseler Holdings, LLC |
|---|---|
| FDA product code | EIX |
| Device type | Probe, Periodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2022-12-01 |
| Record revised | 2023-01-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5026955U0 | In distribution | |
| 5026967U0 | In distribution | |
| 5026969U0 | In distribution | |
| 5028590U0 | In distribution | |
| 5028589U0 | In distribution | |
| 5026954U0 | In distribution | |
| 5028587U0 | In distribution | |
| 5026958U0 | In distribution | |
| 5026956U0 | In distribution | |
| 5026975U0 | In distribution | |
| 5026976U0 | In distribution | |
| 5026960U0 | In distribution | |
| 5026952U0 | In distribution | |
| 5026965U0 | In distribution | |
| 5026953U0 | In distribution | |
| 5026964U0 | In distribution | |
| 5026968U0 | In distribution | |
| 5026970U0 | In distribution | |
| 5026961U0 | In distribution | |
| 5026977U0 | In distribution | |
| 5028592U0 | In distribution | |
| 5028591U0 | In distribution | |
| 5026959U0 | In distribution | |
| 5026963U0 | In distribution | |
| 5026962U0 | In distribution | |
| 5027030U0 | In distribution | |
| 5026971U0 | In distribution | |
| 5028588U0 | 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.