| Primary Device ID | 08800046921428 |
| NIH Device Record Key | fb4e6e53-e82f-4581-97a3-a74dc6356214 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LUXEN Smile, LUXEN Zr |
| Version Model Number | En D98 A2 10T |
| Company DUNS | 688528450 |
| Company Name | DENTALMAX CO.,LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800046921428 [Primary] |
| EIH | Powder, Porcelain |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-14 |
| Device Publish Date | 2022-02-04 |
| 08800046977241 | Zr-10T-D98-HT |
| 08800119910779 | ML 1200 600 Multi P D95 MHT Dark 12T |
| 08800119910762 | ML 1200 600 Multi P D95 MHT Dark 14T |
| 08800119910755 | ML 1200 600 Multi P D95 MHT Dark 16T |
| 08800119910748 | ML 1200 600 Multi P D95 MHT Dark 18T |
| 08800119910731 | ML 1200 600 Multi P D95 MHT Dark 20T |
| 08800119910724 | ML 1200 600 Multi P D95 MHT Dark 22T |
| 08800119910717 | ML 1200 600 Multi P D95 MHT Dark 25T |
| 08800119910700 | ML 1200 600 Multi P D95 MHT Dark 28T |
| 08800119910694 | ML 1200 600 Multi P D95 MHT Dark 30T |
| 08800119910687 | ML 1200 600 Multi P D95 MHT Light 12T |
| 08800119910670 | ML 1200 600 Multi P D95 MHT Light 14T |
| 08800119910663 | ML 1200 600 Multi P D95 MHT Light 16T |
| 08800119910656 | ML 1200 600 Multi P D95 MHT Light 18T |
| 08800119910649 | ML 1200 600 Multi P D95 MHT Light 20T |
| 08800119910632 | ML 1200 600 Multi P D95 MHT Light 22T |
| 08800119910625 | ML 1200 600 Multi P D95 MHT Light 25T |
| 08800119910618 | ML 1200 600 Multi P D95 MHT Light 28T |
| 08800119910601 | ML 1200 600 Multi P D95 MHT Light 30T |
| 08800119910595 | ML 1200 600 Multi P D95 MHT Medium 12T |
| 08800119910588 | ML 1200 600 Multi P D95 MHT Medium 14T |
| 08800119910571 | ML 1200 600 Multi P D95 MHT Medium 16T |
| 08800119910564 | ML 1200 600 Multi P D95 MHT Medium 18T |
| 08800119910557 | ML 1200 600 Multi P D95 MHT Medium 20T |
| 08800119910540 | ML 1200 600 Multi P D95 MHT Medium 22T |
| 08800119910533 | ML 1200 600 Multi P D95 MHT Medium 25T |
| 08800119910526 | ML 1200 600 Multi P D95 MHT Medium 28T |
| 08800119910519 | ML 1200 600 Multi P D95 MHT Medium 30T |
| 08800119910502 | ML 1200 600 Multi P D98 MHT Dark 12T |
| 08800119910496 | ML 1200 600 Multi P D98 MHT Dark 14T |
| 08800119910489 | ML 1200 600 Multi P D98 MHT Dark 16T |
| 08800119910472 | ML 1200 600 Multi P D98 MHT Dark 18T |
| 08800119910465 | ML 1200 600 Multi P D98 MHT Dark 20T |
| 08800119910458 | ML 1200 600 Multi P D98 MHT Dark 22T |
| 08800119910441 | ML 1200 600 Multi P D98 MHT Dark 25T |
| 08800119910434 | ML 1200 600 Multi P D98 MHT Dark 28T |
| 08800119910427 | ML 1200 600 Multi P D98 MHT Dark 30T |
| 08800119910410 | ML 1200 600 Multi P D98 MHT Light 12T |
| 08800119910403 | ML 1200 600 Multi P D98 MHT Light 14T |
| 08800119910397 | ML 1200 600 Multi P D98 MHT Light 16T |
| 08800119910380 | ML 1200 600 Multi P D98 MHT Light 18T |
| 08800119910373 | ML 1200 600 Multi P D98 MHT Light 20T |
| 08800119910366 | ML 1200 600 Multi P D98 MHT Light 22T |
| 08800119910359 | ML 1200 600 Multi P D98 MHT Light 25T |
| 08800119910342 | ML 1200 600 Multi P D98 MHT Light 28T |
| 08800119910335 | ML 1200 600 Multi P D98 MHT Light 30T |
| 08800119910328 | ML 1200 600 Multi P D98 MHT Medium 12T |
| 08800119910311 | ML 1200 600 Multi P D98 MHT Medium 14T |
| 08800119910304 | ML 1200 600 Multi P D98 MHT Medium 16T |
| 08800119910298 | ML 1200 600 Multi P D98 MHT Medium 18T |