Advanced Air System
FDA 510(k) K143704 · W&H Dentalwerk Buermoos GmbH
510(k) numberK143704
Submission
- Device name
- Advanced Air System
- Applicant
- W&H Dentalwerk Buermoos GmbH
Buermoos, AT - Received
- December 29, 2014
- Decision date
- November 23, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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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| 510(k) | Device | Decision |
|---|---|---|
| K253776 | Implantmed Plus II & Piezomed Plus II ModuleDZI · Traditional | 06/18/2026SE |
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| K201703 | PROXEO Twist Cordless Polishing System PL-40 HEKX · Traditional | 02/24/2021SE |
| K181858 | Electric Handpiece MotorEBW · Traditional | 03/26/2019SE |
| K171553 | W&H Assistina TwinEFB · Traditional | 12/08/2017SE |
| K133488 | PiezomedDZI · Traditional | 10/16/2014SE |
| K100600 | Prosthodontic Screwdriver , Model IA-400EKX · Traditional | 07/09/2010SE |
| K083811 | W&H Handpiece Anesto, Model: RA-5EGM · Traditional | 01/14/2010SE |
| K090931 | Cordless Endo Handpieces EB-300, Entran and EB-300 S, S5 Endo MotorEKX · Abbreviated | 12/15/2009SE |
| K090548 | Contra-Angle Handpiece Komet OS30EFB · Abbreviated | 06/30/2009SE |
Questions and answers
When was Advanced Air System cleared by the FDA?
Advanced Air System (K143704) received a 510(k) decision of Substantially Equivalent on November 23, 2015, 329 days after the submission was received.
What is the product code of K143704?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.