MiniKut
MiniKut Molar Sampler Pack (.15/.07, .15/.03, .20/.03, .25/.03, .25/.05, .35/.05) 25mm 6 Pack
53manufacturers in China registered for this device type
52catalogue numbers in this listing
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 | Dental Engineering Laboratories, 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, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-08-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 22 to 140 °F |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1054021 | In distribution | |
| 1463525 | In distribution | |
| 1051531 | In distribution | |
| 1033021 | In distribution | |
| 1032021 | In distribution | |
| 1033025 | In distribution | |
| 1034521 | In distribution | |
| 1052525 | In distribution | |
| 1054031 | In distribution | |
| 1054525 | In distribution | |
| 1031525 | In distribution | |
| 1033525 | In distribution | |
| 1054025 | In distribution | |
| 1430525 | In distribution | |
| 1053021 | In distribution | |
| 1062025 | In distribution | |
| 1052521 | In distribution | |
| 1052021 | In distribution | |
| 1034031 | In distribution | |
| 1051521 | In distribution | |
| 1052025 | In distribution | |
| 1032521 | In distribution | |
| 1051517 | In distribution | |
| 1051525 | In distribution | |
| 1034531 | In distribution | |
| 1053531 | In distribution | |
| 1034025 | In distribution | |
| 1430325 | In distribution | |
| 1054521 | In distribution | |
| 1062021 | In distribution | |
| 1052031 | In distribution | |
| 1053025 | In distribution | |
| 1033031 | In distribution | |
| 1032525 | In distribution | |
| 1032025 | In distribution | |
| 1033531 | In distribution | |
| 1053031 | In distribution | |
| 1053521 | In distribution | |
| 1082521 | In distribution | |
| 1032531 | In distribution | |
| 1071517 | In distribution | |
| 1033521 | In distribution | |
| 1032031 | In distribution | |
| 1052531 | In distribution | |
| 1031531 | In distribution | |
| 1034525 | In distribution | |
| 1053525 | In distribution | |
| 1031521 | In distribution | |
| 1433525 | In distribution | |
| 1034021 | In distribution | |
| 1082525 | In distribution | |
| 1054531 | 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
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.