The following data is part of a premarket notification filed by Axenic Dental, Inc. with the FDA for Axenic Dhp Disposable High-performance Handpiece.
| Device ID | K072754 |
| 510k Number | K072754 |
| Device Name: | AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | AXENIC DENTAL, INC. 259 EAST MICHIGAN AVE. SUITE 409 Kalamazoo, MI 49007 |
| Contact | Joseph T Sobota |
| Correspondent | Joseph T Sobota AXENIC DENTAL, INC. 259 EAST MICHIGAN AVE. SUITE 409 Kalamazoo, MI 49007 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-27 |
| Decision Date | 2008-01-25 |
| Summary: | summary |