The following data is part of a premarket notification filed by Osstell Ab with the FDA for Osstell Isq Implant Stability Meter.
| Device ID | K082523 |
| 510k Number | K082523 |
| Device Name: | OSSTELL ISQ IMPLANT STABILITY METER |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | OSSTELL AB 901 KING STREET SUITE 200 Alexandria, VA 22314 |
| Contact | Cherita James |
| Correspondent | Cherita James OSSTELL AB 901 KING STREET SUITE 200 Alexandria, VA 22314 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-02 |
| Decision Date | 2008-09-26 |
| Summary: | summary |