The following data is part of a premarket notification filed by Directa Ab with the FDA for Luxator Lx Handpiece.
| Device ID | K133178 |
| 510k Number | K133178 |
| Device Name: | LUXATOR LX HANDPIECE |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | DIRECTA AB P.O. BOX 723 Upplands Vasby, SE Se-194 47 |
| Contact | Henric Karsk |
| Correspondent | Henric Karsk DIRECTA AB P.O. BOX 723 Upplands Vasby, SE Se-194 47 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2015-11-24 |