Integra® Miltex®
Spreader, Root Canal, D11, Single, Black-Blue, Tactile Tone™
17manufacturers in China registered for this device type
69catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (5), Shanghai (4), Jiangsu (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| 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 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Shanghai Smedent Medical Instrument Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 30 |
| CDM Center OF Excellence Ltd. | Beijing | Beijing | Manufacturer | 29 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Huizhou Videya Technology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 18 |
| Gavin Biotechnology Co., Ltd. | Jinzhong | Shanxi | Manufacturer | 16 |
| Henan Lusterdent Medical Instrument Co., Ltd. | Zhengzhou | Henan | Manufacturer | 15 |
Showing 12 of 17. All 17 manufacturers in China registered for Spreader, Pulp Canal Filling Material, Endodontic
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | EKK |
| Device type | Spreader, Pulp Canal Filling Material, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-07-03 |
| Record revised | 2022-07-15 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2023-12-04 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 012-23044 | 6 | Withdrawn | |
| 017-24520 | Withdrawn | ||
| 012-23172 | 6 | Withdrawn | |
| 017-24420 | Withdrawn | ||
| UE30NT | Withdrawn | ||
| UE25NT | Withdrawn | ||
| 012-23042 | 6 | Withdrawn | |
| 017-24421 | Withdrawn | ||
| 012-23164 | 6 | Withdrawn | |
| UED11-KB | Withdrawn | ||
| 012-14900 | 6 | Withdrawn | |
| 012-19602 | 6 | Withdrawn | |
| 012-14904 | 6 | Withdrawn | |
| 012-23162 | 6 | Withdrawn | |
| UEGP3-KB | Withdrawn | ||
| 012-14902 | 6 | Withdrawn | |
| 012-14903 | 6 | Withdrawn | |
| 017-24440 | Withdrawn | ||
| 012-23035 | 6 | Withdrawn | |
| UED11T | Withdrawn | ||
| 012-19605 | 6 | Withdrawn | |
| UE25 | Withdrawn | ||
| 017-24415 | Withdrawn | ||
| 012-23171 | 6 | Withdrawn | |
| UEM1N | Withdrawn | ||
| 012-23041 | 6 | Withdrawn | |
| 012-23043 | 6 | Withdrawn | |
| 012-23166 | Withdrawn | ||
| UED11TN | Withdrawn | ||
| 012-23161 | 6 | Withdrawn | |
| 012-23037 | 6 | Withdrawn | |
| 012-23175 | 6 | Withdrawn | |
| UED11 | Withdrawn | ||
| 017-24411 | Withdrawn | ||
| 012-23045 | 6 | Withdrawn | |
| 012-19601 | 6 | Withdrawn | |
| 017-24441 | Withdrawn | ||
| 017-24442 | Withdrawn | ||
| 012-19606 | 6 | Withdrawn | |
| 012-23036 | 6 | Withdrawn | |
| 012-14901 | 6 | Withdrawn | |
| UE45 | Withdrawn | ||
| 012-14906 | Withdrawn | ||
| 012-19607 | Withdrawn | ||
| 012-23040 | 6 | Withdrawn | |
| 017-24521 | Withdrawn | ||
| 017-24450 | Withdrawn | ||
| 012-23046 | Withdrawn | ||
| 012-14905 | 6 | Withdrawn | |
| UE55 | Withdrawn | ||
| 012-19604 | 6 | Withdrawn | |
| 012-23163 | 6 | Withdrawn | |
| UE40 | Withdrawn | ||
| 017-24445 | Withdrawn | ||
| 012-23039 | Withdrawn | ||
| 012-50130 | Withdrawn | ||
| 012-23173 | 6 | Withdrawn | |
| 012-23034 | 6 | Withdrawn | |
| UED11BL | Withdrawn | ||
| 012-23176 | Withdrawn | ||
| UE40NT | Withdrawn | ||
| 017-24451 | Withdrawn | ||
| UEGP3BL | Withdrawn | ||
| 012-23174 | 6 | Withdrawn | |
| 012-19603 | 6 | Withdrawn | |
| 012-50140 | Withdrawn | ||
| 017-24410 | Withdrawn | ||
| 012-14807 | Withdrawn | ||
| 012-23170 | 6 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 51 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 33 |
| Pluggers | Diadent Group Intl., Inc. | 32 |
| Spreaders | Diadent Group Intl., Inc. | 32 |
| American Eagle Instruments | American Eagle Instruments | 30 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 30 |
| 3D Endo | 3D Dental Designs AND Development, LLC | 30 |
| Mani Spreaders | Mani, Inc. | 15 |
| Spreaders | FKG Dentaire Sàrl | 14 |
| Premier Spreader | Premier Dental Products Co. | 11 |
| Henry Schein | Henry Schein, Inc. | 10 |
| Tapered Finger Spreader NiTi | Maillefer Instruments Holding Sàrl | 10 |
Showing 12 of 40. All products under Spreader, Pulp Canal Filling Material, 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.