| Primary Device ID | 00815619021847 |
| NIH Device Record Key | f52ac5a7-fb96-4a26-95cd-6ea6859b8776 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EXACTA Temp Xtra |
| Version Model Number | Shade B1 |
| Catalog Number | NB1-FS |
| Company DUNS | 016325552 |
| Company Name | EXACTA DENTAL PRODUCTS INC |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 00815619021847 [Primary] |
| EBG | Crown And Bridge, Temporary, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-30 |
| 00815619021861 | Shade C2 |
| 00815619021854 | Shade Bleach |
| 00815619021847 | Shade B1 |
| 00815619021830 | Shade A3.5 |
| 00815619021823 | Shade A3 |
| 00815619021816 | Shade A2 |
| 00815619021809 | Shade A1 |
| 00815619020703 | Shade C2 |
| 00815619020697 | Shade BL |
| 00815619020680 | Shade B1 |
| 00815619020673 | Shade A3.5 |
| 00815619020666 | Shade A3 |
| 00815619020659 | Shade A2 |
| 00815619020642 | Shade A1 |