| Primary Device ID | D080SSEACXX32XLW050 |
| NIH Device Record Key | 13d758c3-91d3-41bc-9d08-39c53cefe24c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EFUCERA AC |
| Version Model Number | 8*1SET,32,L,W0.5 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |