| Primary Device ID | D161230810 |
| NIH Device Record Key | 253be6e5-1932-4e15-9dfe-8f447f099726 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AxioFlow |
| Version Model Number | 23081 Trial Pack Shade A3.5 |
| Company DUNS | 119330625 |
| Company Name | Axiodent 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 | false |
| Device Combination Product | false |
| Single Use | true |
| 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 |
|---|---|
| HIBCC | D161230810 [Primary] |
| EBF | Material, Tooth Shade, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-20 |
| Device Publish Date | 2024-11-12 |
| D161230990 | 23099 Trial Pack Shade Opaque |
| D161230980 | 23098 Trial Pack Shade Incisal |
| D161230970 | 23097 Trial Pack Shade Bleach |
| D161230960 | 23096 Trial Pack Shade G4 |
| D161230950 | 23095 Trial Pack Shade G3 |
| D161230940 | 23094 Trial Pack Shade G2 |
| D161230930 | 23093 Trial Pack Shade G1 |
| D161230920 | 23092 Trial Pack Shade OA3.5 |
| D161230910 | 23091 Trial Pack Shade OA3 |
| D161230900 | 23090 Trial Pack Shade OA2 |
| D161230890 | 23089 Trial Pack Shade OA1 |
| D161230880 | 23088 Trial Pack Shade C3 |
| D161230870 | 23087 Trial Pack Shade C2 |
| D161230860 | 23086 Trial Pack Shade C1 |
| D161230850 | 23085 Trial Pack Shade B3 |
| D161230840 | 23084 Trial Pack Shade B2 |
| D161230830 | 23083 Trial Pack Shade B1 |
| D161230820 | 23082 Trial Pack Shade A4 |
| D161230810 | 23081 Trial Pack Shade A3.5 |
| D161230800 | 23080 Trial Pack Shade A3 |
| D161230790 | 23079 Trial Pack Shade A2 |