Surgic Pro, Surgic Pro+
FDA 510(k) K173905 · Nakanishi, Inc.
510(k) numberK173905
Submission
- Device name
- Surgic Pro, Surgic Pro+
- Applicant
- Nakanishi, Inc.
Kanuma-Shi, JP - Received
- December 22, 2017
- Decision date
- June 19, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)EBW · Traditional | Nakanishi, Inc. | 06/20/2024SE |
| K230895 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3…EBW · Traditional | Cefla S.C. | 04/01/2024SE |
| K231864 | Fiber Optic Brushless Electronic Micromotor, model: iM100EBW · Traditional | Codent Technical Industry Co., Ltd. | 03/11/2024SE |
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More from Guilin Woodpecker Medical Instrument Co., Ltd.
| 510(k) | Device | Decision |
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| 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 Surgic Pro, Surgic Pro+ cleared by the FDA?
Surgic Pro, Surgic Pro+ (K173905) received a 510(k) decision of Substantially Equivalent on June 19, 2018, 179 days after the submission was received.
What is the product code of K173905?
The FDA product code is EBW – Controller, Foot, Handpiece And Cord, a Class I (low risk) device regulated under 21 CFR 872.4200.