| Primary Device ID | 00850194007831 |
| NIH Device Record Key | 81d19cf4-d305-460b-9f6d-e1bbbdf771df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VistaCORE 25ml Cartridge Shade A2 |
| Version Model Number | 1 |
| Company DUNS | 018651672 |
| Company Name | APEX DENTAL MATERIALS INCORPORATED |
| 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 | 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 | 00850194007831 [Primary] |
| EMA | Cement, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-23 |
| Device Publish Date | 2019-12-13 |
| 00850194007787 - Purify+ Gel 5 Pack | 2019-12-23 Purify+ Gel 5 Pack |
| 00850194007794 - Purify+ Liquid 5 Pack | 2019-12-23 Purify+ Liquid 5 Pack |
| 00850194007800 - VistaCORE 5ml Syringe Shade A2 | 2019-12-23 VistaCORE 5ml Syringe Shade A2 |
| 00850194007817 - VistaCORE 5ml Syringe Shade White Opaque | 2019-12-23 VistaCORE 5ml Syringe Shade White Opaque |
| 00850194007824 - VistaCORE 25ml Cartridge Shade White Opaque | 2019-12-23 VistaCORE 25ml Cartridge Shade White Opaque |
| 00850194007831 - VistaCORE 25ml Cartridge Shade A2 | 2019-12-23VistaCORE 25ml Cartridge Shade A2 |
| 00850194007831 - VistaCORE 25ml Cartridge Shade A2 | 2019-12-23 VistaCORE 25ml Cartridge Shade A2 |
| 00850194007848 - VistaCORE 25ml Cartridge Kit Shade A2 | 2019-12-23 VistaCORE 25ml Cartridge Kit Shade A2 |
| 00850194007855 - VistaCORE 25ml Cartridge Kit Shade White Opaque | 2019-12-23 VistaCORE 25ml Cartridge Kit Shade White Opaque |