Henry Schein
ACCLEAN Hands-free HVE Standard Kit (2 Long Hoses, 6 Short Hoses with Adapters, 100 Leaves, 5 mini leaves, IFU)
49manufacturers in China registered for this device type
18catalogue numbers in this listing
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 | Henry Schein, Inc., United States |
|---|---|
| FDA product code | EHZ |
| Device type | Evacuator, Oral Cavity |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6640 |
| Premarket notification | Exempt |
| Record published | 2019-01-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Pack of 4, pack of 8, case of 20, case of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1126331 | 250 | In distribution | |
| 1000944 | In distribution | ||
| 5701406 | 144 | In distribution | |
| 5701405 | 144 | In distribution | |
| 5703899 | In distribution | ||
| 5703900 | In distribution | ||
| 1004568 | 50 | In distribution | |
| 1029023 | 25 | In distribution | |
| 5701408 | 144 | In distribution | |
| 5701404 | 144 | In distribution | |
| 5700241 | 100 | In distribution | |
| 5701407 | 144 | In distribution | |
| 5703901 | In distribution | ||
| 5700242 | 100 | In distribution | |
| 1014856 | 50 | In distribution | |
| 5700240 | 100 | In distribution | |
| 1012270 | 25 | In distribution | |
| 1002365 | 25 | In distribution |
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 |
| 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 |
| Advance Dental Products | THE Atlanta Dental Supply Company | 8 |
Showing 12 of 546. All products under Evacuator, Oral Cavity
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.