| Primary Device ID | 08800046906630 |
| NIH Device Record Key | fd490bb2-25c1-41da-bdd8-f304a866c11e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LUXEN Zr |
| Version Model Number | LUXEN 1100-16T-D95-MB3 |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800046906630 [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 | 2019-05-16 |
| Device Publish Date | 2019-05-08 |
| 08800046907231 | LUXEN 1100-30T-D95-MD4 |
| 08800046907224 | LUXEN 1100-25T-D95-MD4 |
| 08800046907217 | LUXEN 1100-22T-D95-MD4 |
| 08800046907200 | LUXEN 1100-18T-D95-MD4 |
| 08800046907194 | LUXEN 1100-16T-D95-MD4 |
| 08800046907187 | LUXEN 1100-14T-D95-MD4 |
| 08800046907170 | LUXEN 1100-12T-D95-MD4 |
| 08800046907163 | LUXEN 1100-30T-D95-MD3 |
| 08800046907156 | LUXEN 1100-25T-D95-MD3 |
| 08800046907149 | LUXEN 1100-22T-D95-MD3 |
| 08800046907132 | LUXEN 1100-18T-D95-MD3 |
| 08800046907125 | LUXEN 1100-16T-D95-MD3 |
| 08800046907118 | LUXEN 1100-14T-D95-MD3 |
| 08800046907101 | LUXEN 1100-12T-D95-MD3 |
| 08800046907095 | LUXEN 1100-30T-D95-MD2 |
| 08800046907088 | LUXEN 1100-25T-D95-MD2 |
| 08800046907071 | LUXEN 1100-22T-D95-MD2 |
| 08800046907064 | LUXEN 1100-18T-D95-MD2 |
| 08800046907057 | LUXEN 1100-16T-D95-MD2 |
| 08800046907040 | LUXEN 1100-14T-D95-MD2 |
| 08800046907033 | LUXEN 1100-12T-D95-MD2 |
| 08800046907026 | LUXEN 1100-30T-D95-MC4 |
| 08800046907019 | LUXEN 1100-25T-D95-MC4 |
| 08800046907002 | LUXEN 1100-22T-D95-MC4 |
| 08800046906999 | LUXEN 1100-18T-D95-MC4 |
| 08800046906982 | LUXEN 1100-16T-D95-MC4 |
| 08800046906975 | LUXEN 1100-14T-D95-MC4 |
| 08800046906968 | LUXEN 1100-12T-D95-MC4 |
| 08800046906951 | LUXEN 1100-25T-D95-MC3 |
| 08800046906944 | LUXEN 1100-25T-D95-MC3 |
| 08800046906937 | LUXEN 1100-22T-D95-MC3 |
| 08800046906920 | LUXEN 1100-18T-D95-MC3 |
| 08800046906913 | LUXEN 1100-16T-D95-MC3 |
| 08800046906906 | LUXEN 1100-14T-D95-MC3 |
| 08800046906890 | LUXEN 1100-12T-D95-MC3 |
| 08800046906883 | LUXEN 1100-30T-D95-MC2 |
| 08800046906876 | LUXEN 1100-25T-D95-MC2 |
| 08800046906869 | LUXEN 1100-22T-D95-MC2 |
| 08800046906852 | LUXEN 1100-18T-D95-MC2 |
| 08800046906845 | LUXEN 1100-16T-D95-MC2 |
| 08800046906838 | LUXEN 1100-14T-D95-MC2 |
| 08800046906821 | LUXEN 1100-12T-D95-MC2 |
| 08800046906814 | LUXEN 1100-30T-D95-MC1 |
| 08800046906807 | LUXEN 1100-25T-D95-MC1 |
| 08800046906791 | LUXEN 1100-22T-D95-MC1 |
| 08800046906784 | LUXEN 1100-18T-D95-MC1 |
| 08800046906777 | LUXEN 1100-16T-D95-MC1 |
| 08800046906760 | LUXEN 1100-14T-D95-MC1 |
| 08800046906753 | LUXEN 1100-12T-D95-MC1 |
| 08800046906746 | LUXEN 1100-30T-D95-MB4 |