Power Dental USA
X Power Flex Interproximal Contouring IPC Extremely Flexible
5manufacturers in China registered for this device type
39catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (4), Shandong (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 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Shanghai Dochem Industries Co., Ltd. | Shanghai | Shanghai | Manufacturer | 45 |
| Shanghai Smedent Medical Instrument Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 30 |
Record
| Listed by | Power Dental U.S.A. Inc. |
|---|---|
| FDA product code | EKH |
| Device type | Carver, Dental Amalgam, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2021-06-20 |
| Record revised | 2023-03-17 (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 | 2023-03-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2509 | In distribution | |
| 2513 | In distribution | |
| 6702 | In distribution | |
| 2523 | In distribution | |
| 2707 | In distribution | |
| 2503 | In distribution | |
| 2712 | In distribution | |
| 2501 | In distribution | |
| 6703 | In distribution | |
| 2512 | In distribution | |
| 2502 | In distribution | |
| 2620 | In distribution | |
| 2702 | In distribution | |
| 6705 | In distribution | |
| 2710 | In distribution | |
| 2711 | In distribution | |
| 2501F | In distribution | |
| 2501T | In distribution | |
| 2506 | In distribution | |
| 2609 | In distribution | |
| 6701 | In distribution | |
| 2504 | In distribution | |
| 6610 | In distribution | |
| 2708 | In distribution | |
| 2508 | In distribution | |
| 2709 | In distribution | |
| 2507 | In distribution | |
| 6612 | In distribution | |
| 6706 | In distribution | |
| 6704 | In distribution | |
| 2505 | In distribution | |
| 2510 | In distribution | |
| 2515 | In distribution | |
| 2514 | In distribution | |
| 2511 | In distribution | |
| 2502T | In distribution | |
| 2520 | In distribution | |
| 2524 | Withdrawn | |
| 2608 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 284 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 154 |
| American Eagle Instruments | American Eagle Instruments | 72 |
| Zoll-Dental | Zoll-Dental | 43 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 38 |
| Sklar® | Sklar Corporation | 33 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 29 |
| Reicodent | Devemed Gmbh | 29 |
| Premier Carvers | Premier Dental Products Co. | 20 |
| J & J Instruments Inc | J & J Instruments, LLC | 20 |
| devemed | Devemed Gmbh | 16 |
| PDT, Inc. | PDT, Inc. | 16 |
Showing 12 of 41. All products under Carver, Dental Amalgam, 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.