Shenzhen Soga Technology Co., Ltd.
Registered establishment in Shenzhen, Guangdong, China. 7 device types, 3 clearances.
Shenzhen Soga Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Knife, Surgical, Probe, Periodontic and 5 other device types. Its earliest product listing with the FDA dates from 2021.
7device types registered with the FDA
3510(k) clearances
Registration
| Registered name | SHENZHEN SOGA TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3018318562 |
| FEI number | 3018318562 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳索感科技有限公司 |
|---|---|
| Unified social credit code | 9144030033513190XK |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Room 1001, Office Building 1, Shenzhen MITK Semiconductor Co., Ltd., No. 6Shiben Road, Sanzhuli Community |
| Postal code | 518108 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Agent, Polishing, Abrasive, Oral Cavity | Class 1 | AIR-FLY | 2024 | 25 |
| Knife, Surgical | Class 1 | Ultrasonic Piezo Bone Surgery SOGA-B1 | 2026 | 8 |
| Laser, Dental, Soft Tissue | Class 2 | Oral Er:YAG laser therapy system (Aurora-S), Dental Diode Laser (ILaser I Pro,ILaser III Pro), Family of Love Dental Laser System(Love Laser), Family of Love Dental Laser System(Love Pen), Laser oral therapy device, PDT-I and 2 more | 2022 | 5 |
| Motor, Surgical Instrument, Ac-Powered | Class 1 | Dental Implant Unit SOGA – S | 2026 | 7 |
| Powered Laser Surgical Instrument | Class 2 | Oral Er:YAG laser therapy system (Aurora-S), Dental Diode Laser (ILaser I Pro,ILaser III Pro), Family of Love Dental Laser System(Love Laser), Dental Diode Laser,Oral Er:YAG laser therapy system,Fiber optic tip, Dental Diode Laser (ILaser II,ILaser II Pro) | 2022 | 92 |
| Probe, Periodontic | Class 1 | Soga -T1, Periodontal Probe Series | 2021 | 34 |
| Syringe, Irrigating (Dental) | Class 1 | Electric Oral Anesthesia Injector, Smart I,Smart II,Smart III | 2021 | 22 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K253309 | 2026-05-19 | NVK | Traditional | This company |
| K211150 | 2022-07-01 | NVK | Abbreviated | This company |
| K214008 | 2022-05-10 | NVK | Abbreviated | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2015 |
|---|---|
| Main products | Dental anesthesia, Diode laser, Periodontal probe, Photodynamic therapy device, Implant motor |
| Certifications | ISO 13485, FDA, CE |
| Export markets | International markets (entered 2021) |
Nearby Manufacturers
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.
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