CARE3 Plus
FDA 510(k) K081811 · Nakanishi, Inc.
510(k) numberK081811
Submission
- Device name
- CARE3 Plus
- Applicant
- Nakanishi, Inc.
Washington, DC, US - Received
- June 26, 2008
- Decision date
- January 21, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K251389 | High speed air turbine handpieceEFB · Traditional | Foshan Topmed Dental Co., Ltd. | 01/12/2026SE |
| K251388 | Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES…EFB · Traditional | Foshan Topmed Dental Co., Ltd. | 01/12/2026SE |
| K242179 | Synea Fusion Handpieces (Intensiv & Profin)EFB · Traditional | W&H Dentalwerk Bürmoos GmbH | 02/28/2025SE |
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| K241074 | High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low…EFB · Traditional | Foshan Soco Precision Instrument Co., Ltd. | 11/12/2024SE |
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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 |
| K232243 | EVO 700 series high speed handpieceEFB · Special | Ttbio Corp. | 08/23/2023SE |
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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 CARE3 Plus cleared by the FDA?
CARE3 Plus (K081811) received a 510(k) decision of Substantially Equivalent on January 21, 2009, 209 days after the submission was received.
What is the product code of K081811?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.