Devemed
dev-lux 3.0 mm | Periolux Area: approximal (mesial, distal) F-LINE | RS | straight, silver-coded
5manufacturers in China registered for this device type
31catalogue 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 | Devemed Gmbh, Germany |
|---|---|
| FDA product code | EKD |
| Device type | Instrument, Cutting, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-04-21 |
| Record revised | 2021-02-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 796-7 A | In distribution | |
| 753-11 F | In distribution | |
| PPS 1600 F | In distribution | |
| 2500-19 F | In distribution | |
| 753-43 F | In distribution | |
| 753-33 F | In distribution | |
| 796-7 | In distribution | |
| PPS 1400 F | In distribution | |
| 753-15 F | In distribution | |
| 796-17 A | In distribution | |
| 796-7 S | In distribution | |
| 753-05 F | In distribution | |
| 2500-15 F | In distribution | |
| 796-3 | In distribution | |
| 753-10 F | In distribution | |
| KL 15-16 F | In distribution | |
| 753-41 F | In distribution | |
| 796-1 | In distribution | |
| PPS 1200 F | In distribution | |
| 753-31 F | In distribution | |
| 796-2 | In distribution | |
| 753-16 F | In distribution | |
| 2500-14 F | In distribution | |
| OR 1-2 F | In distribution | |
| 796-17 | In distribution | |
| PPS 1210 F | In distribution | |
| 2500-18 F | In distribution | |
| 2500-13 F | In distribution | |
| 796-8 | In distribution | |
| 2500-17 F | In distribution | |
| 796-1 M | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 365 |
| Blue AND Green | Nordent Manufacturing Inc | 43 |
| Reicodent | Devemed Gmbh | 29 |
| Instrument, Cutting, Operative | Jota AG | 15 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 12 |
| Burkhart Dental | Nordent Manufacturing Inc | 11 |
| 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.