Concentrix MX-AC High-Speed Handpiece
FDA 510(k) K173465 · Dentalez, Inc.
510(k) numberK173465
Submission
- Device name
- Concentrix MX-AC High-Speed Handpiece
- Applicant
- Dentalez, Inc.
Lancaster, PA, US - Received
- November 8, 2017
- Decision date
- March 28, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K192412 | SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece…EFB · Traditional | 01/06/2020SE |
| K162397 | Titan 3 Low Speed Angle AttachmentsEGS · Traditional | 01/19/2017SE |
| K153411 | 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW…EFB · Traditional | 04/08/2016SE |
| K113301 | Concenpiece,High-Speed Handpiece SeriesEFB · Traditional | 01/23/2012SE |
| K093072 | Starcare Handpiece Maintenance UnitEFB · Traditional | 12/28/2009SE |
| K070869 | Prophy Star 3 Hygiene Handpiece, Model 264422EFB · Traditional | 06/15/2007SE |
Questions and answers
When was Concentrix MX-AC High-Speed Handpiece cleared by the FDA?
Concentrix MX-AC High-Speed Handpiece (K173465) received a 510(k) decision of Substantially Equivalent on March 28, 2018, 140 days after the submission was received.
What is the product code of K173465?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.