Power Dental USA
ORTHODONTIC DISTAL END CUTTER, T/C SAFTY HOLD LONG HANDLE 14.5cm Max. wire size, .020 .018 x .025
10manufacturers in China registered for this device type
18catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Guangdong (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Aplus (Guangzhou) Medical Technology Company | Guangzhou | Guangdong | Contract manufacturer | 6 |
| 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 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Jiangsu Taimedical Technology Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 6 |
Record
| Listed by | Power Dental U.S.A. Inc. |
|---|---|
| FDA product code | HXZ |
| Device type | Cutter, Wire |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2021-06-20 |
| Record revised | 2025-03-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Latex | Labelled latex-free |
| Distribution end date | 2022-12-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5632 | In distribution | |
| 5624 | In distribution | |
| 5604 | In distribution | |
| 5602 | In distribution | |
| 5603N2 | In distribution | |
| 5602HN | In distribution | |
| 5601 | In distribution | |
| 5607 | In distribution | |
| 5609 | In distribution | |
| 5602N | In distribution | |
| 5601NXL | In distribution | |
| 5607K | In distribution | |
| 5603 | In distribution | |
| 5601L | In distribution | |
| 5601F | In distribution | |
| 5604N2 | In distribution | |
| 5601S | In distribution | |
| 5608K | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| gSource | Gsource, LLC. | 56 |
| Ambler Surgical | Ambler Surgical, LLC | 44 |
| Millennium | Avalign Technologies, Inc. | 36 |
| V. Mueller | Steris Corporation | 32 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 31 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 31 |
| Schwert | A. Schweickhardt Gmbh & Co. KG | 29 |
| Orthomed | Ortho-MED, Inc. | 24 |
| Tecomet | Tecomet, Inc. | 24 |
| Cutter, Wire | Synthes Gmbh | 22 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 22 |
| Kmedic | Teleflex Medical LLC | 20 |
Showing 12 of 175. All products under Cutter, Wire
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.