Darby Dental Supply, LLC
Lentulo Paste Filler 25MM #35
17manufacturers in China registered for this device type
33catalogue 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 | Darby Dental Supply, LLC |
|---|---|
| FDA product code | EKK |
| Device type | Spreader, Pulp Canal Filling Material, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2022-05-12 |
| Record revised | 2022-06-10 (version 2) |
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, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9517712 | 4 | In distribution | |
| 9544410 | 6 | In distribution | |
| 9533400 | 4 | In distribution | |
| 9517713 | 4 | In distribution | |
| 9517710 | 4 | In distribution | |
| 9544420 | 6 | In distribution | |
| 9533424 | 4 | In distribution | |
| 9517700 | 4 | In distribution | |
| 9533404 | 4 | In distribution | |
| 9533422 | 4 | In distribution | |
| 9544422 | 6 | In distribution | |
| 9544404 | 6 | In distribution | |
| 9533426 | 4 | In distribution | |
| 9517711 | 4 | In distribution | |
| 9544426 | 6 | In distribution | |
| 9533402 | 4 | In distribution | |
| 9544402 | 6 | In distribution | |
| 5257332 | In distribution | ||
| 9544428 | 6 | In distribution | |
| 9517706 | 4 | In distribution | |
| 9533428 | 4 | In distribution | |
| 9544408 | 6 | In distribution | |
| 9517709 | 4 | In distribution | |
| 9533406 | 4 | In distribution | |
| 9533408 | 4 | In distribution | |
| 9544406 | 6 | In distribution | |
| 9528026 | 6 | In distribution | |
| 9517705 | 4 | In distribution | |
| 5257334 | In distribution | ||
| 9544400 | 6 | In distribution | |
| 9544424 | 6 | In distribution | |
| 9517708 | 4 | In distribution | |
| 5257333 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Miltex® | Integra LifeSciences Production Corporation | 69 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 51 |
| 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.