Power Dental USA
X Power Titanium Black Scaler Sets SET OF 8
4manufacturers in China registered for this device type
24catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), 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 Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
Record
| Listed by | Power Dental U.S.A. Inc. |
|---|---|
| FDA product code | EMK |
| Device type | Curette, Surgical, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2021-06-20 |
| Record revised | 2023-05-15 (version 6) |
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 | 2023-03-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1622 | In distribution | |
| 1918 | In distribution | |
| 1610 | In distribution | |
| 1907 | In distribution | |
| 1628 | In distribution | |
| 1250T | In distribution | |
| 1625 | In distribution | |
| 1518 | In distribution | |
| 1619 | In distribution | |
| 1501 | In distribution | |
| 1416 | In distribution | |
| 1422 | In distribution | |
| 1702 | In distribution | |
| 1503 | In distribution | |
| 1626 | In distribution | |
| 1613 | In distribution | |
| 1627 | In distribution | |
| 1606 | Withdrawn | |
| 1611 | Withdrawn | |
| 1609 | Withdrawn | |
| 1608 | Withdrawn | |
| 1605 | Withdrawn | |
| 1602 | Withdrawn | |
| 1601 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 693 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 170 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 112 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 85 |
| Schwert | A. Schweickhardt Gmbh & Co. KG | 72 |
| Paul Banditt | Terlain Enterprises, Inc. | 52 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 45 |
| Sklar® | Sklar Corporation | 40 |
| Anatomic Colours | Aesculap AG | 39 |
| Zoll-Dental | Zoll-Dental | 39 |
| Aesculap | Aesculap AG | 39 |
| devemed | Devemed Gmbh | 33 |
Showing 12 of 107. All products under Curette, 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.