LUXEN Zr, LUXEN Smile
Dentalmax Co., Ltd
DENTALMAX CO., LTD
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014980456 | 3014980456 | DENTALMAX CO., LTD | 1 | N | 2026-01-01 | 50-7, Pungsesandan 2-ro, Pungse-myeon, Dongnam-gu Cheonan-si Chungnam KR 31217 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 224130 | 1371893150 | K241151 | LUXEN 5G | EIH | 2024-09-30 |
| 224130 | 2057274254 | K212548 | LUXEN CL Dental Liquid | EIH | 2021-12-06 |
| 224130 | 1071277792 | K171585 | LUXEN Zr, LUXEN Smile | EIH | 2018-10-31 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| EIH | 3 | 2024-09-30 |