The following data is part of a premarket notification filed by Osstell Ab with the FDA for Osstell Idx.
| Device ID | K142358 |
| 510k Number | K142358 |
| Device Name: | Osstell IDx |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | OSSTELL AB STAMPGATAN 14 Gothenburg, SE 41101 |
| Contact | Karin Breding |
| Correspondent | Karin Breding OSSTELL AB STAMPGATAN 14 Gothenburg, SE 41101 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-25 |
| Decision Date | 2015-02-19 |
| Summary: | summary |