Power Dental U.S.A., Inc.
Cavitron Endo 18AG/25K Ultrasonic Unit, Endodontic Insert Unit Power Setting: LOW-MED
110manufacturers in China registered for this device type
23catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (31), Jiangsu (27), Guangdong (20). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Dongguan Hong De Medical Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Yiwu Haoding Medical Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 23 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
Showing 12 of 110. All 110 manufacturers in China registered for Instrument, Manual, Surgical, General Use
Record
| Listed by | Power Dental U.S.A. Inc. |
|---|---|
| FDA product code | MDM |
| Device type | Instrument, Manual, Surgical, General Use |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2021-06-20 |
| Record revised | 2022-12-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Distribution end date | 2022-12-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N7826-1 | In distribution | |
| N1990-1G | In distribution | |
| N1990-2G | In distribution | |
| N1977T | In distribution | |
| N1953T | In distribution | |
| N8001 | In distribution | |
| N4124 | In distribution | |
| N7615 | In distribution | |
| N1984N | In distribution | |
| N1990-3G | In distribution | |
| N88612 | In distribution | |
| N1831 | In distribution | |
| N7826-0 | In distribution | |
| N7613 | Withdrawn | |
| N88611 | Withdrawn | |
| N8001S | Withdrawn | |
| N7614 | Withdrawn | |
| N7605 | Withdrawn | |
| N1990-4G | Withdrawn | |
| N4123 | Withdrawn | |
| N4122 | Withdrawn | |
| N4125 | Withdrawn | |
| N7609 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 1,686 |
| TSI | Tedan Surgical Innovations, L.L.C. | 1,181 |
| Medfix | Medfix International, LLC | 514 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 446 |
| Fentex | Fentex medical GmbH | 407 |
| Millennium | Avalign Technologies, Inc. | 337 |
| Synergetics | Synergetics USA, Inc. | 312 |
| American Medicals | American Medicals | 298 |
| gSource | Gsource, LLC. | 291 |
| Life Instruments | Life Instrument Corp. | 274 |
| Ambler Surgical | Ambler Surgical, LLC | 272 |
| Instrument, Manual, Surgical, General Use | Karl Storz GmbH & Co. KG | 261 |
Showing 12 of 1,364. All products under Instrument, Manual, Surgical, General Use
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.