Devemed
SWE | Periolux 3.0 | 1.5 mm # DE3 |165mm deep fractured and decayed roots, straight H-Type A
6manufacturers in China registered for this device type
102catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Changsha Nice Medical Instrument Limited Company | Changsha | Hunan | Manufacturer | 17 |
Record
| Listed by | Devemed Gmbh, Germany |
|---|---|
| FDA product code | EMJ |
| Device type | Elevator, Surgical, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-04-21 |
| Record revised | 2020-12-04 (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 |
|---|---|---|
| 790-1 | In distribution | |
| 675-20 F | In distribution | |
| 750-05 | In distribution | |
| 751-07 | In distribution | |
| 67 R | In distribution | |
| 752-10 | In distribution | |
| 750-07 | In distribution | |
| 750-08 | In distribution | |
| 63 | In distribution | |
| 750-02 | In distribution | |
| 792-3 F | In distribution | |
| 792-6 F | In distribution | |
| 60 L | In distribution | |
| 54 | In distribution | |
| 53 | In distribution | |
| 792-2 F | In distribution | |
| 60 U | In distribution | |
| 792-11 F | In distribution | |
| 52 | In distribution | |
| 790-3 | In distribution | |
| 790-2 | In distribution | |
| 60 R | In distribution | |
| 751-06 | In distribution | |
| 47 | In distribution | |
| 47 U | In distribution | |
| 775-9 F | In distribution | |
| 680-3 | In distribution | |
| 680-11 | In distribution | |
| 751-01 | In distribution | |
| 750-01 | In distribution | |
| 680-5 | In distribution | |
| 60 | In distribution | |
| 675-15 F | In distribution | |
| 26 P | In distribution | |
| 675-10 F | In distribution | |
| 17 | In distribution | |
| 752-32 | In distribution | |
| 680-10 | In distribution | |
| 725-3 | In distribution | |
| 793-AS-1N | In distribution | |
| 794-61 | In distribution | |
| 752-30 | In distribution | |
| 792-1 F | In distribution | |
| 794-62 | In distribution | |
| 675-05 F | In distribution | |
| 752-80 | In distribution | |
| 794-341 | In distribution | |
| 794-60 | In distribution | |
| 794-342 | In distribution | |
| 66 B | In distribution | |
| 25 | In distribution | |
| 680-4 | In distribution | |
| 675-25 F | In distribution | |
| 680-2 | In distribution | |
| 21 | In distribution | |
| 25 P | In distribution | |
| 775-10 F | In distribution | |
| 740-10 F | In distribution | |
| 675-35 F | In distribution | |
| 780-2 F | In distribution | |
| 675-30 F | In distribution | |
| 680-12 | In distribution | |
| 793-AS-3 | In distribution | |
| 68 R | In distribution | |
| 60 B | In distribution | |
| 792-5 F | In distribution | |
| 1 | In distribution | |
| 751-02 | In distribution | |
| 680-1 | In distribution | |
| 751-00 | In distribution | |
| 752-36 | In distribution | |
| 752-34 | In distribution | |
| 65 | In distribution | |
| 725-4 | In distribution | |
| 68 L | In distribution | |
| 750-04 | In distribution | |
| 752-82 | In distribution | |
| 66 | In distribution | |
| 750-09 | In distribution | |
| 680-13 | In distribution | |
| 32 | In distribution | |
| 793-AS-2N | In distribution | |
| 793-AS-3N | In distribution | |
| 67 L | In distribution | |
| 794-340 | In distribution | |
| 752-50 | In distribution | |
| 780-1 F | In distribution | |
| 750-06 | In distribution | |
| 793-AS-2 | In distribution | |
| 24 P | In distribution | |
| 752-20 | In distribution | |
| 680-6 | In distribution | |
| 752-52 | In distribution | |
| 675-27 F | In distribution | |
| 792-4 F | In distribution | |
| 720-100 | In distribution | |
| 675-22 F | In distribution | |
| 751-05 | In distribution | |
| 793-AS-1 | In distribution | |
| 69 | In distribution | |
| 750-03 | In distribution | |
| 26 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 465 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 264 |
| Power Dental USA | Power Dental U.S.A. Inc. | 247 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 233 |
| Elevator | KLS-Martin L.P. | 231 |
| Kohdent | Kohler Medizintechnik GmbH | 206 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 153 |
| Stoma® | Storz AM Mark Gmbh | 150 |
| Reicodent | Devemed Gmbh | 142 |
| Sklar | Sklar Corporation | 130 |
| Osung MND | Osung MND Co., Ltd. | 126 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 121 |
Showing 12 of 743. All products under Elevator, Surgical, Dental
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.