Oral Surgery System and Accessories
FDA 510(k) K152125 · Bonart Co., Ltd.
510(k) numberK152125
Submission
- Device name
- Oral Surgery System and Accessories
- Applicant
- Bonart Co., Ltd.
Xinzhuang Dist., TW - Received
- July 31, 2015
- Decision date
- August 15, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K162856 | Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)EGS · Abbreviated | 07/18/2017SE |
| K100785 | Bonart Model ART-IM1 Implantor System & AccessoriesEBW · Traditional | 12/03/2010SE |
| K082971 | Bonart ART-L5 LED Cordless Curing LightEBZ · Traditional | 11/13/2008SE |
| K081550 | Bonart Ultrasonic Scaler, Moedls ART-P3II Pro and Art-Mii ProELC · Traditional | 08/28/2008SE |
| K080761 | Bonart's Arteotomy Omi and Opi Ultrasonic Surgery System & AccessoriesDZI · Traditional | 08/25/2008SE |
| K071981 | Bonart Model ART-P6 Piezo Electric Ultrasonic Scaler & Accessories (Tips)ELC · Traditional | 10/26/2007SE |
| K062289 | Bonart ART-L3 LED Curing LightEBZ · Traditional | 01/03/2007SE |
| K061448 | Bonart ART-P3II & P4 Piezo Electric Ultrasonic Scaler Units with AccessoriesELC · Traditional | 08/17/2006SE |
| K052028 | Bonart ART-M3II & M4 Ultrasonic Scaler Units with Accessories (Inserts)ELC · Traditional | 10/28/2005SE |
| K023721 | Bonart ART-L2 Light Curing UnitEBZ · Traditional | 01/10/2003SE |
Questions and answers
When was Oral Surgery System and Accessories cleared by the FDA?
Oral Surgery System and Accessories (K152125) received a 510(k) decision of Substantially Equivalent on August 15, 2016, 381 days after the submission was received.
What is the product code of K152125?
The FDA product code is DZI – Drill, Bone, Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4120.