ProFile NT Rotary File
Profile NT .06 ISO 20/25mm Rotary File
53manufacturers in China registered for this device type
80catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (13), Jiangsu (8), Shanghai (7). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Denjoy Dental Co., Ltd. | Changsha | Hunan | Contract manufacturer | 17 |
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Shenzhen Superline Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 12 |
| Wuhu Guli Ortho Co., Ltd. | Wuhu | Anhui | Contract manufacturer | 12 |
| Shenzhen Forever Medical Devices Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Zhejiang Eksen Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 9 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
Showing 12 of 53. All 53 manufacturers in China registered for File, Pulp Canal, Endodontic
Record
| Listed by | Tulsa Dental Products LLC, United States |
|---|---|
| FDA product code | EKS |
| Device type | File, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-07-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PIT062025 | In distribution | |
| PIT022525 | In distribution | |
| PIT061521 | In distribution | |
| PIT043530 | In distribution | |
| PIT044021 | In distribution | |
| PIT022025 | In distribution | |
| PIT047021 | In distribution | |
| PIT063521 | In distribution | |
| PIT042530 | In distribution | |
| PIT042025 | In distribution | |
| PIT063030 | In distribution | |
| PIT04A1530 | In distribution | |
| PIT023521 | In distribution | |
| PIT064521 | In distribution | |
| PIT048025 | In distribution | |
| PIT063530 | In distribution | |
| PIT024525 | In distribution | |
| PIT063025 | In distribution | |
| PIT063525 | In distribution | |
| PIT062030 | In distribution | |
| PIT042521 | In distribution | |
| PIT064030 | In distribution | |
| PIT043521 | In distribution | |
| PIT064025 | In distribution | |
| PIT045521 | In distribution | |
| PIT064530 | In distribution | |
| PIT024021 | In distribution | |
| PIT045530 | In distribution | |
| PIT042525 | In distribution | |
| PIT045021 | In distribution | |
| PIT044521 | In distribution | |
| PIT044530 | In distribution | |
| PIT043025 | In distribution | |
| PIT048021 | In distribution | |
| PIT04A1525 | In distribution | |
| PIT046025 | In distribution | |
| PIT044025 | In distribution | |
| PIT043030 | In distribution | |
| PIT062525 | In distribution | |
| PIT062530 | In distribution | |
| PIT044030 | In distribution | |
| PIT065021 | In distribution | |
| PIT042030 | In distribution | |
| PIT061525 | In distribution | |
| PIT065030 | In distribution | |
| PIT064021 | In distribution | |
| PIT04A4521 | In distribution | |
| PIT042021 | In distribution | |
| PIT021525 | In distribution | |
| PIT047025 | In distribution | |
| PIT045025 | In distribution | |
| PIT024521 | In distribution | |
| PIT047030 | In distribution | |
| PIT063021 | In distribution | |
| PIT046021 | In distribution | |
| PIT022021 | In distribution | |
| PIT021521 | In distribution | |
| PIT048030 | In distribution | |
| PIT062021 | In distribution | |
| PIT044525 | In distribution | |
| PIT065025 | In distribution | |
| PIT023021 | In distribution | |
| PIT04A1521 | In distribution | |
| PIT04A4530 | In distribution | |
| PIT045030 | In distribution | |
| PIT041530 | In distribution | |
| PIT061530 | In distribution | |
| PIT062521 | In distribution | |
| PIT023525 | In distribution | |
| PIT023025 | In distribution | |
| PIT064525 | In distribution | |
| PIT045525 | In distribution | |
| PIT022521 | In distribution | |
| PIT041525 | In distribution | |
| PIT046030 | In distribution | |
| PIT024025 | In distribution | |
| PIT043525 | In distribution | |
| PIT043021 | In distribution | |
| PIT04A4525 | In distribution | |
| PIT041521 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Henry Schein | Henry Schein, Inc. | 720 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 658 |
| Endodontic Hand Instruments | Tulsa Dental Products LLC | 612 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 526 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 456 |
| 3D Endo | 3D Dental Designs AND Development, LLC | 283 |
| Avalon Biomed | Shenzhen Denco Medical Co., Ltd. | 233 |
| KP | Guilin Kevin Peter Technology Co., Ltd. | 216 |
| Dctaper | SS White Burs LLC | 205 |
| Advance Dental Products | THE Atlanta Dental Supply Company | 205 |
| Edge File | US Endodontics, LLC | 202 |
| Komet Root Canal Files | Gebr. Brasseler Gmbh & Co. KG | 199 |
Showing 12 of 1,536. All products under File, Pulp Canal, Endodontic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K933582 | 1993-10-20 |
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.