Ti-Max X Turbine
FDA 510(k) K113655 · Nakanishi, Inc.
510(k) numberK113655
Submission
- Device name
- Ti-Max X Turbine
- Applicant
- Nakanishi, Inc.
Richardson, TX, US - Received
- December 12, 2011
- Decision date
- March 5, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K233122 | High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800…EFB · Traditional | Litu Tech , Ltd. | 04/30/2024SE |
| K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)EFB · Traditional | Nakanishi, Inc. | 04/25/2024SE |
| K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsEFB · Traditional | Foshan Coxo Medical Instrument Co., Ltd. | 09/22/2023SE |
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| K260773 | Varios Combi Pro2ELC · Traditional | 03/10/2026SE |
| K254163 | VarioSurg 4DZI · Traditional | 12/23/2025SE |
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| 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 Ti-Max X Turbine cleared by the FDA?
Ti-Max X Turbine (K113655) received a 510(k) decision of Substantially Equivalent on March 5, 2012, 84 days after the submission was received.
What is the product code of K113655?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.