The following data is part of a premarket notification filed by Osstell Ab with the FDA for Osstell Beacon.
| Device ID | K181888 |
| 510k Number | K181888 |
| Device Name: | Osstell Beacon |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | Osstell AB Stampgaten 14 Gotenborg, SE 41101 |
| Contact | Stefan Horn |
| Correspondent | Cherita James M Squared Associates, Inc 575 8th Ave Suite 1212 New York, NY 10018 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-13 |
| Decision Date | 2019-08-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09010522000861 | K181888 | 000 |
| 09010522002360 | K181888 | 000 |
| 09010522002407 | K181888 | 000 |
| 09010522002391 | K181888 | 000 |
| 09010522002384 | K181888 | 000 |
| 09010522002131 | K181888 | 000 |
| 09010522002117 | K181888 | 000 |
| 09010522002087 | K181888 | 000 |
| 09010522002469 | K181888 | 000 |