| Primary Device ID | 08800053082808 |
| NIH Device Record Key | 8352405f-64f6-4adb-9642-4ad28b0431fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MESHEET075 |
| Version Model Number | MESHEET075 |
| 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 | 08800053082808 [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 |
| 08800053099318 - Drill Holder | 2024-08-28 Drill Holder (DDH53) |
| 08800266940094 - SQ Guide Long Drill | 2024-08-28 SQ Guide Long Drill (DSQGLD) |
| 08800266940971 - s-Clean MU Digital Lab | 2024-08-28 s-Clean MU Digital Lab (DSMUDLS) |
| 08800266940988 - i-Clean Digital Lab Analog | 2024-08-28 i-Clean Digital Lab Analog (DIDLARS) |
| 08800266940995 - i-Clean Digital Lab Analog | 2024-08-28 i-Clean Digital Lab Analog (DIDLAWS) |
| 08800266941022 - s-Clean ScanBody | 2024-08-28 s-Clean ScanBody (DSSBRLFS) |
| 08800266941039 - s-Clean ScanBody | 2024-08-28 s-Clean ScanBody (DSSBMLFS) |
| 08800266941046 - s-Clean ScanBody | 2024-08-28 s-Clean ScanBody (DSSBNLFS) |