Variosurg
FDA 510(k) K073678 · Nakanishi, Inc.
510(k) numberK073678
Submission
- Device name
- Variosurg
- Applicant
- Nakanishi, Inc.
Washington, DC, US - Received
- December 28, 2007
- Decision date
- July 10, 2008
- 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 |
|---|---|---|
| K260773 | Varios Combi Pro2ELC · Traditional | 03/10/2026SE |
| K254163 | VarioSurg 4DZI · Traditional | 12/23/2025SE |
| K252662 | UniBurHBE · Traditional | 09/19/2025SE |
| K251689 | Varios 170 Lux Scaler System (VA170LUXS10); Varios 170 Lux Scaler System (VA170LUXS11)…ELC · Traditional | 09/19/2025SE |
| K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System…EFB · Traditional | 09/20/2024SE |
| K233288 | NLZ Built-In Motor SystemEBW · Traditional | 06/24/2024SE |
| K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)EBW · Traditional | 06/20/2024SE |
| K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)EFB · Traditional | 04/25/2024SE |
| K230888 | Titanium TurbineEFB · Traditional | 06/02/2023SE |
| K230106 | General Cutting StraightEGS · Traditional | 05/24/2023SE |
Questions and answers
When was Variosurg cleared by the FDA?
Variosurg (K073678) received a 510(k) decision of Substantially Equivalent on July 10, 2008, 195 days after the submission was received.
What is the product code of K073678?
The FDA product code is DZI – Drill, Bone, Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4120.