PROPHYflex 4
FDA 510(k) K181110 · Kaltenbach & Voigt GmbH
510(k) numberK181110
Submission
- Device name
- PROPHYflex 4
- Applicant
- Kaltenbach & Voigt GmbH
Biberach, DE - Received
- April 27, 2018
- Decision date
- April 10, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EFB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K240337 | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)EFB · Traditional | Guangdong Jinme Medical Technology Co., Ltd. | 11/13/2024SE |
| K241074 | High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low…EFB · Traditional | Foshan Soco Precision Instrument Co., Ltd. | 11/12/2024SE |
| K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System…EFB · Traditional | Nakanishi, Inc. | 09/20/2024SE |
| 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 |
More from Ttbio Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K182712 | DEXIS CariVu 3-in-1 by KaVoNTK · Traditional | 11/23/2019SE |
| K163239 | SMARTmaticEFA · Traditional | 03/17/2017SE |
| K161488 | ESTETICA Dental Treatment Unit and AccessoriesEIA · Traditional | 12/08/2016SE |
| K143465 | MASTERmatic LUXEFA · Traditional | 04/09/2015SE |
| K140308 | Mastersurg / ExpertsurgEBW · Traditional | 08/15/2014SE |
| K130560 | Mastertorque Lux 8900 LEFB · Traditional | 09/27/2013SE |
| K123402 | DiagnocamNTK · Traditional | 09/24/2013SE |
| K103027 | Electrotorque TLCEBW · Traditional | 08/19/2011SE |
| K092446 | Intra Lux Head 3 LdsyEFA · Traditional | 11/03/2009SE |
| K080677 | Comfortronic 4894 and Comfortdrive 200XDA HandpieceEIA · Traditional | 06/06/2008SE |
Questions and answers
When was PROPHYflex 4 cleared by the FDA?
PROPHYflex 4 (K181110) received a 510(k) decision of Substantially Equivalent on April 10, 2019, 348 days after the submission was received.
What is the product code of K181110?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.