Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L
FDA 510(k) K150076 · Dong IL Technology , Ltd.
510(k) numberK150076
Submission
- Device name
- Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L
- Applicant
- Dong IL Technology , Ltd.
Hwaseong-Si, Gyeonggi-Do, KR - Received
- January 14, 2015
- Decision date
- June 2, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code DZI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253655 | Angled Screwdriver MED (M-SD090)DZI · Traditional | W&H Dentalwerk Bürmoos GmbH | 07/31/2026SE |
| K253776 | Implantmed Plus II & Piezomed Plus II ModuleDZI · Traditional | W&H Dentalwerk Buermoos GmbH | 06/18/2026SE |
| K254163 | VarioSurg 4DZI · Traditional | Nakanishi, Inc. | 12/23/2025SE |
| K242432 | MT-BoneDZI · Traditional | Mectron S.P.A. | 08/19/2024SE |
| K240340 | Surgical Drive System (Model: ES70, ES90, E8)DZI · Traditional | Guangdong Jinme Medical Technology Co., Ltd. | 07/18/2024SE |
| K231087 | Guided Surgery KitDZI · Traditional | Implant Direct Sybron Manufacturing, LLC | 08/16/2023SE |
| K192561 | Traus SUS20DZI · Traditional | Saeshin Precision Co., Ltd. | 07/13/2020SE |
| K200265 | Surgical DrillsDZI · Traditional | Implant Direct Sybron Manufacturing, LLC | 06/30/2020SE |
| K192033 | Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC…DZI · Traditional | Bennett Jacoby, Dds, Ms, Inc. | 06/09/2020SE |
| K172137 | Piezotome CubeDZI · Traditional | Satelec - Acteon Group | 05/03/2018SE |
More from Satelec - Acteon Group
| 510(k) | Device | Decision |
|---|---|---|
| K110881 | Ultrasonic Surgical UnitDZI · Traditional | 12/16/2011SE |
Questions and answers
When was Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L cleared by the FDA?
Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L (K150076) received a 510(k) decision of Substantially Equivalent on June 2, 2015, 139 days after the submission was received.
What is the product code of K150076?
The FDA product code is DZI – Drill, Bone, Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4120.