SURGmatic S15 L Pro
SURGmatic S15 L Pro is an electrically driven dental handpiece for oral surgery and general dental procedures. Its uses include extraction, root resection, osteotomy, removal of decay and…
SURGmatic S15 L Pro is an electrically driven dental handpiece for oral surgery and general dental procedures. Its uses include extraction, root resection, osteotomy, removal of decay and preparation of teeth, cavities, crowns or fillings. It is used by trained dental or oral surgery professionals.
An external motor supplies rotary movement through the coupling to gears and shafts within the handpiece. These drive the bur at the treatment site. A collet holds the bur, which is released with a push button mechanism. The handpiece also transmits light from the motor to the working area.
Listed Item
The SURGmatic S15 L Pro handpiece is intended for: • Oral, jaw and facial surgery • Tooth extraction procedures • Root resection • Osteotomy • Removal of carious material • Tooth, cavity and crown preparations • Processing of fillings The SURGmatic S15 L Pro is for use by a trained professional in the field of general dentistry and / or oral surgery.
Connection and Reprocessing
The reusable handpiece uses an ISO 3964 motor connection and compatible ISO 1797 burs. It can be steam sterilized, and its fibre optic transmitter provides illumination at the bur end.
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 | Kavo Dental Gmbh, Germany |
|---|---|
| FDA product code | EGS |
| Device type | Handpiece, Contra- And Right-Angle Attachment, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4200 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K213139 |
| Record published | 2022-03-11 |
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 |
|---|---|---|
| 1.014.4000 | In distribution |
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 |
|---|---|
| K213139 | 2021-12-21 |
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.