Burkhart Dental
BDS Composite Inst 4 DE Large PAD TIN #6
5manufacturers in China registered for this device type
11catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1), Guangxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Shanghai Fanta Dental Materials Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Changzhou Bomedent Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
Record
| Listed by | Nordent Manufacturing Inc |
|---|---|
| FDA product code | EKD |
| Device type | Instrument, Cutting, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2020-05-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization, Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PFI4T/6BH | In distribution | |
| PFI8A/BH | In distribution | |
| PFI20T/6BH | In distribution | |
| PFIG4-5/BH | In distribution | |
| PFI1T/6BH | In distribution | |
| PFI117ST/6BH | In distribution | |
| PFI6/BH | In distribution | |
| PFIW-2/BH | In distribution | |
| PFI11/BH | In distribution | |
| PFI3T/6BH | In distribution | |
| PFI23T/6BH | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 365 |
| Blue AND Green | Nordent Manufacturing Inc | 43 |
| devemed | Devemed Gmbh | 31 |
| Reicodent | Devemed Gmbh | 29 |
| Instrument, Cutting, Operative | Jota AG | 15 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 12 |
| National Distribution & Contracting Inc. | Nordent Manufacturing Inc | 11 |
| J&J Instruments | J & J Instruments, LLC | 10 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 9 |
| Zoll-Dental | Zoll-Dental | 9 |
| Henry Schein | Henry Schein, Inc. | 9 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 8 |
Showing 12 of 36. All products under Instrument, Cutting, Operative
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.