| Primary Device ID | 00815619020703 | 
| NIH Device Record Key | ee12f6a8-2464-4207-9a9e-8c2488d64253 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | EXACTA Temp Xtra | 
| Version Model Number | Shade C2 | 
| Catalog Number | 1-NC2-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 |