| Primary Device ID | D080XXJSP1PCS30CLE0 |
| NIH Device Record Key | 2d0513f9-e746-47c4-8851-bd1f7188a92f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | JUSTI PRODUCTS OEM DISK |
| Version Model Number | 1PC,30MM,CLEAR |
| Company DUNS | 693430001 |
| Company Name | YAMAHACHI DENTAL MFG.,CO. |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
|---|---|
| HIBCC | D080XXJSP1PCS30CLE0 [Primary] |
| EBI | Resin, Denture, Relining, Repairing, Rebasing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-10 |
| Device Publish Date | 2023-10-02 |
| D080XXJSP1PCS30ORG0 | 1PC,30MM,ORIGINAL |
| D080XXJSP1PCS30LRP0 | 1PC,30MM,LIGHT REDDISH PINK |
| D080XXJSP1PCS30LGT0 | 1PC,30MM,LIGHT |
| D080XXJSP1PCS30DRP0 | 1PC,30MM,DARK PINK |
| D080XXJSP1PCS30CLE0 | 1PC,30MM,CLEAR |
| D080XXJSP1PCS25ORG0 | 1PC,25MM,ORIGINAL |
| D080XXJSP1PCS25LRP0 | 1PC,25MM,LIGHT REDDISH PINK |
| D080XXJSP1PCS25LGT0 | 1PC,25MM,LIGHT |
| D080XXJSP1PCS25DRP0 | 1PC,25MM,DARK PINK |
| D080XXJSP1PCS25CLE0 | 1PC,25MM,CLEAR |
| D080XXJSP1PCS20ORG0 | 1PC,20MM,ORIGINAL |
| D080XXJSP1PCS20LRP0 | 1PC,20MM,LIGHT REDDISH PINK |
| D080XXJSP1PCS20LGT0 | 1PC,20MM,LIGHT |
| D080XXJSP1PCS20DRP0 | 1PC,20MM,DARK PINK |
| D080XXJSP1PCS20CLE0 | 1PC,20MM,CLEAR |