SURGmatic S201 L Pro
Catalogue number 1.013.7540, listed by Kavo Dental Gmbh, Germany, under Controller, Foot, Handpiece And Cord. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangxi (2), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Guangxi Ehall Medical Technology Co., Ltd. | Nanning | Guangxi | Manufacturer | 17 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
Record
| Listed by | Kavo Dental Gmbh, Germany |
|---|---|
| FDA product code | EBW |
| Device type | Controller, Foot, Handpiece And Cord |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4200 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K140308 |
| Record published | 2020-01-24 |
| Record revised | 2024-02-22 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature -29 to 50 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1.013.7540 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| A-dec | A-dec, Inc. | 43 |
| X-Cube | Saeshin Precision Co., Ltd. | 22 |
| Maxso | Beyes Dental Canada, Inc. | 20 |
| NLZ | Nakanishi Inc. | 16 |
| Surgic Pro | Nakanishi Inc. | 15 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 13 |
| DTE | Guilin Woodpecker Medical Instrument Co., Ltd. | 11 |
| woodpecker | Guilin Woodpecker Medical Instrument Co., Ltd. | 10 |
| NL400 | Nakanishi Inc. | 9 |
| NLX | Nakanishi Inc. | 9 |
| Surgic XT Plus | Nakanishi Inc. | 6 |
| Axiom® | Etablissements Anthogyr | 6 |
Showing 12 of 256. All products under Controller, Foot, Handpiece And Cord
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.