| Primary Device ID | D161230710 |
| NIH Device Record Key | 1ce4feb3-e0b9-439c-85ce-f439d702d934 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AxioComp NT |
| Version Model Number | 23071 20 x 0.25g unit dose compules Shade OA2 |
| 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 | D161230710 [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 |
| D161230550 | 23055 20 x 0.25g unit dose compules Shade A2 |
| D161230540 | 23054 Refill Pack Shade Gingival G4 |
| D161230530 | 23053 Refill Pack Shade Gingival G3 |
| D161230520 | 23052 Refill Pack Shade Gingival G2 |
| D161230510 | 23051 Refill Pack Shade Gingival G1 |
| D161230500 | 23050 Refill Pack Shade Bleach |
| D161230490 | 23049 Refill Pack Shade Extra Bleach |
| D161230480 | 23048 Refill Pack Shade OA3 |
| D161230470 | 23047 Refill Pack Shade OA2 |
| D161230460 | 23046 Refill Pack Shade OA1 |
| D161230450 | 23045 Refill Pack Shade Opaque |
| D161230440 | 23044 Refill Pack Shade Incisal |
| D161230430 | 23043 Refill Pack Shade D3 |
| D161230420 | 23042 Refill Pack Shade D2 |
| D161230410 | 23041 Refill Pack Shade D1 |
| D161230400 | 23040 Refill Pack Shade C3 |
| D161230390 | 23039 Refill Pack Shade C2 |
| D161230380 | 23038 Refill Pack Shade C1 |
| D161230370 | 23037 Refill Pack Shade B3 |
| D161230360 | 23036 Refill Pack Shade B2 |
| D161230350 | 23035 Refill Pack Shade B1 |
| D161230340 | 23034 Refill Pack Shade A4 |
| D161230330 | 23033 Refill Pack Shade A3.5 |
| D161230320 | 23032 Refill Pack Shade A3 |
| D161230310 | 23031 Refill Pack Shade A2 |
| D161230780 | 23078 20 x 0.25g unit dose compules Shade Gingival |
| D161230770 | 23077 20 x 0.25g unit dose compules Shade Gingival |
| D161230760 | 23076 20 x 0.25g unit dose compules Shade Gingival |
| D161230750 | 23075 20 x 0.25g unit dose compules Shade Gingival |
| D161230740 | 23074 20 x 0.25g unit dose compules Shade Bleach |
| D161230730 | 23073 20 x 0.25g unit dose compules Shade Extra Bl |
| D161230720 | 23072 20 x 0.25g unit dose compules Shade OA3 |
| D161230710 | 23071 20 x 0.25g unit dose compules Shade OA2 |
| D161230700 | 23070 20 x 0.25g unit dose compules Shade OA1 |
| D161230690 | 23069 20 x 0.25g unit dose compules Shade Opaque |
| D161230680 | 23068 20 x 0.25g unit dose compules Shade Incisal |
| D161230670 | 23067 20 x 0.25g unit dose compules Shade D3 |
| D161230660 | 23066 20 x 0.25g unit dose compules Shade D2 |
| D161230650 | 23065 20 x 0.25g unit dose compules Shade D1 |
| D161230640 | 23064 20 x 0.25g unit dose compules Shade C3 |
| D161230630 | 23063 20 x 0.25g unit dose compules Shade C2 |
| D161230620 | 23062 20 x 0.25g unit dose compules Shade C1 |
| D161230610 | 23061 20 x 0.25g unit dose compules Shade B3 |
| D161230600 | 23060 20 x 0.25g unit dose compules Shade B2 |
| D161230590 | 23059 20 x 0.25g unit dose compules Shade B1 |
| D161230580 | 23058 20 x 0.25g unit dose compules Shade A4 |
| D161230570 | 23057 20 x 0.25g unit dose compules Shade A3.5 |
| D161230560 | 23056 20 x 0.25g unit dose compules Shade A3 |