Metal Dento-Infusor Tip
Metal DI Tips 500pk Dual Thread
Who Else Makes It
Concentrated in Shanghai (12), Guangdong (8), Anhui (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 |
| Hefei Xingcheng Sanitary Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 21 |
| Nanchang White Technology Co., Ltd. | Nanchang | Jiangxi | Contract manufacturer | 21 |
| Sino-Vista Dental Instruments Co., Ltd. | Zibo | Shandong | Contract manufacturer | 15 |
| Wuxi Yushou Medical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 8 |
| Shanghai Bing FAN Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| medmix China Ltd | Shanghai | Shanghai | Contract manufacturer | 2 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
Showing 12 of 49. All 49 manufacturers in China registered for Syringe, Restorative And Impression Material
Record
| Listed by | Ultradent Products Inc., United States |
|---|---|
| FDA product code | EID |
| Device type | Syringe, Restorative And Impression Material |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-04-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2560 | In distribution | |
| 2558 | In distribution | |
| 2559 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Power Dental USA | Power Dental U.S.A. Inc. | 92 |
| Henry Schein | Henry Schein, Inc. | 44 |
| Accessory | Bisco, Inc. | 26 |
| Mixing Tips | Kettenbach Gmbh & Co KG | 20 |
| Defend | Young Innovations Inc. | 20 |
| Plasdent | Plasdent Corp. | 19 |
| Mixing Tips | Kerr Corporation | 18 |
| Health-Tec/DHP Mixing Tips | Dental Health Products Inc | 17 |
| Advance Dental Products | THE Atlanta Dental Supply Company | 17 |
| Aeliteflo | Bisco, Inc. | 16 |
| Mixing tips | Voco Gmbh | 15 |
| 3M™ RelyX™ | 3M Deutschland GmbH | 15 |
Showing 12 of 575. All products under Syringe, Restorative And Impression Material
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-12-14 | Class II | Device Design | Ultradent Products, Inc. announces a voluntary field action for the NanoTips 30g 20pk, 100pk because the cannula attached to the tip hub may become loose or detach from the blue base that connects to the syringe. | 143 packs of 100 tips; 104 packs of 20 tips | 2017-06-05 |
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.