The following data is part of a premarket notification filed by Handpiece Headquarters with the FDA for Maxima Xtend Handpiece Maintenance System.
| Device ID | K143183 |
| 510k Number | K143183 |
| Device Name: | Maxima XTEND Handpiece Maintenance System |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | HANDPIECE HEADQUARTERS 620 S. PLACENTIA AVE. Placentia, CA 92870 |
| Contact | Timothy Ropchan |
| Correspondent | Sonny Phung HANDPIECE HEADQUARTERS 620 S. PLACENTIA AVE. Placentia, CA 92870 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-05 |
| Decision Date | 2015-02-17 |
| Summary: | summary |