Digit Power™ Dispenser
digit Power Dispenser Kit - ISO Threaded Connector
49manufacturers in China registered for this device type
5catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (11), Guangdong (9), Jiangsu (8). 11 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 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Zhejiang Jasmine Oralcare Products Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 17 |
| Sino-Vista Dental Instruments Co., Ltd. | Zibo | Shandong | Contract manufacturer | 15 |
| Cixi Qimei Combination Tool Packing Factory | Cixi | Shanghai | Contract manufacturer | 10 |
| Yongqing Huaguan Dental Instruments Factory | Langfang | Hebei | Contract manufacturer | 9 |
| Dongguan Junhai Medical Device Co., Ltd. | Dong Guang | Guangdong | Contract manufacturer | 9 |
| Dacheng Huaguan Dental Instruments Co., Ltd. | Langfang | Hebei | Contract manufacturer | 4 |
| Wenzhou K.L.F. Medical Plastics Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
Showing 12 of 49. All 49 manufacturers in China registered for Evacuator, Oral Cavity
Record
| Listed by | Dentsply LLC, United States |
|---|---|
| FDA product code | EHZ |
| Device type | Evacuator, Oral Cavity |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6640 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-04-02 |
| Record revised | 2022-10-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from sunlight. Keep dry. |
| Distribution end date | 2024-05-03 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 678062 | 1x dispenser, 1x extra grip, 1x extra cap, 50x disposable barrier sleeves | Withdrawn | |
| 678061 | 1x dispenser, 1x extra grip, 1x extra cap, 50x disposable barrier sleeves | Withdrawn | |
| 678063 | 1x dispenser, 1x extra grip, 1x extra cap, 50x disposable barrier sleeves | Withdrawn | |
| 678060 | 1x dispenser, 1x extra grip, 1x extra cap, 50x disposable barrier sleeves | Withdrawn | |
| 678538 | 3x Cartridge Caps | 3 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DCI | DCI International, LLC | 89 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 73 |
| Salvin Dental Specialties | Salvin Dental Specialties, LLC | 39 |
| A-dec | A-dec, Inc. | 37 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 34 |
| Unipack | Unipack LLC | 24 |
| Henry Schein | Henry Schein, Inc. | 18 |
| Zoll-Dental | Zoll-Dental | 14 |
| Euvac | Plasdent Corp. | 14 |
| Osung MND | Osung MND Co., Ltd. | 12 |
| JMU | JMU Dental, Inc | 10 |
| Keystone Industries | Keystone Industries | 10 |
Showing 12 of 546. All products under Evacuator, Oral Cavity
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K782068 | 1979-01-26 |
| K781488 | 1978-09-27 |
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.