Spreader
Catalogue number 43-507-06-07, listed by KLS-Martin L.P., United States, under Spreader, Pulp Canal Filling Material, Endodontic. 17 manufacturers in China are registered for this product code.
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 | KLS-Martin L.P., United States |
|---|---|
| FDA product code | EKK |
| Device type | Spreader, Pulp Canal Filling Material, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-26 |
| Record revised | 2022-06-10 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2021-04-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 43-507-06-07 | 16 CM | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Miltex® | Integra LifeSciences Production Corporation | 69 |
| 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 |
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.