The following data is part of a premarket notification filed by Dentalez, Inc. with the FDA for Concentrix Mx-ac High-speed Handpiece.
| Device ID | K173465 |
| 510k Number | K173465 |
| Device Name: | Concentrix MX-AC High-Speed Handpiece |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | DentalEZ, Inc. 1816 Colonial Village Lane Lancaster, PA 17601 |
| Contact | Dan Laskowitz |
| Correspondent | Kay Engle DentalEZ, Inc. 1816 Colonial Village Lane Lancaster, PA 17601 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-08 |
| Decision Date | 2018-03-28 |
| Summary: | summary |