The following data is part of a premarket notification filed by Dentalmax Co., Ltd with the FDA for Luxen Zr, Luxen Smile.
| Device ID | K171585 |
| 510k Number | K171585 |
| Device Name: | LUXEN Zr, LUXEN Smile |
| Classification | Powder, Porcelain |
| Applicant | Dentalmax Co., Ltd 50-7, Pungsesandan 2-ro Pungse-myeon, Dongnam-gu Cheonan-si, KR 31217 |
| Contact | Jindong Kim |
| Correspondent | Jindong Kim Dentalmax Co., Ltd 50-7, Pungsesandan 2-ro Pungse-myeon, Dongnam-gu Cheonan-si, KR 31217 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-31 |
| Decision Date | 2018-10-31 |
| Summary: | summary |