Endo-Express
Endo-Express Reciprocating Handpiece Replacement Head
9manufacturers in China registered for this device type
4catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (2), Guangxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Premium Plus (Dongguan) Limited | Dongguan | Guangdong | Repacker / relabeller | 34 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 13 |
| Foshan Soco Precision Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 4 |
| Foshan Topmed Dental Co., Ltd. | Foshan | Guangdong | Manufacturer | 2 |
| Foshan Wenjian Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 2 |
Record
| Listed by | Essential Dental Systems, Inc., United States |
|---|---|
| FDA product code | EGS |
| Device type | Handpiece, Contra- And Right-Angle Attachment, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4200 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-07-10 |
| Record revised | 2023-11-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2022-01-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5500-00 | In distribution | |
| 5500TEP | In distribution | |
| 5520-00 | Withdrawn | |
| 5510-00 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premium Plus | Premium Plus International Limited | 366 |
| Young | Young Dental Manufacturing I, LLC | 94 |
| Henry Schein | Henry Schein, Inc. | 84 |
| StarDental Instrument Solutions | Dentalez, Inc. | 63 |
| Maxso | Beyes Dental Canada, Inc. | 42 |
| Nupro® | Dentsply Professional | 35 |
| AllPro | Team Technologies, Inc. | 30 |
| Medidenta | Medidenta | 28 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 23 |
| Maxima | Henry Schein, Inc. | 21 |
| Denticator | Young Dental Manufacturing I, LLC | 19 |
| Henry Schein | Young Dental Manufacturing I, LLC | 17 |
Showing 12 of 247. All products under Handpiece, Contra- And Right-Angle Attachment, Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K111541 | 2012-03-16 |
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.