| Primary Device ID | 08800053082815 |
| NIH Device Record Key | fdee0598-5e24-4549-90e9-7d11d3655a0b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MESHEET075-R |
| Version Model Number | MESHEET075-R |
| Company DUNS | 694721181 |
| Company Name | DENTIS 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 | true |
| 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 | 08800053082815 [Primary] |
| NXC | Aligner, Sequential |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-13 |
| Device Publish Date | 2024-03-05 |
| 08800053091305 - Luvis Chair (LC700C-chair only) | 2024-04-03 A Dental Chair to provide patient supporting and positioning during dental treatment. |
| 08806169138965 - s-Clean Ratchet Driver | 2024-04-02 s-Clean Ratchet Driver (DRMDSEL) |
| 08800053082808 - MESHEET075 | 2024-03-13 MESHEET075 |
| 08800053082815 - MESHEET075-R | 2024-03-13 |
| 08800053082815 - MESHEET075-R | 2024-03-13 |
| 08800053042093 - DENOPS | 2024-01-31 DC : 3.7 V, 550mh(Battery) |
| 08800053045032 - LUVIS-C600 Series | 2024-01-31 AC 100-240 V, 50-60 Hz, 30-45 VA |
| 08800053045049 - LUVIS-C600 Series | 2024-01-31 AC 100-240 V, 50-60 Hz, 30-45 VA |
| 08800053045056 - LUVIS-C600 Series | 2024-01-31 AC 100-240 V, 50-60 Hz, 30-45 VA |