| Primary Device ID | 00858290006345 |
| NIH Device Record Key | 48090e6e-5219-4688-9edc-7d3d3167207d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Smart Advantage GI A2 kit 30 ampoules |
| Version Model Number | 675A23000 |
| Company DUNS | 002863526 |
| Company Name | ELEVATE ORAL CARE, LLC |
| Device Count | 30 |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858290006345 [Primary] |
| GS1 | 00858290006376 [Unit of Use] |
| 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 | 2019-06-18 |
| Device Publish Date | 2019-06-10 |
| 00858290006734 - FluoriMax Cotton Candy | 2024-12-20 FluoriMax 2.5% NaF Varnish Cotton Candy Flavor flow through ampoules 70 pack |
| 00858290006918 - Papacarie | 2024-12-20 Papacarie Kit - 1 ml syringe |
| 00858290006932 - Povi-One | 2024-12-20 Povi-One/FluoriMax Varnish BG Convenience Bottle Kit - 8ml bottle |
| 00858290006598 - DenteShield Sample Opaque with Fluoride | 2024-12-03 DenteShield Sample Opaque with Fluoride |
| 00858290006895 - Povi-One | 2023-10-05 Povi-One Unit Dose, .45ml, Demo 2pk |
| 00858290006888 - Advantage Arrest | 2023-07-31 Advantage Arrest, Convenience Kit |
| 00858290006871 - Allday Spray/Gel Sample Bag | 2023-05-26 Dry Mouth Spray and Gel, Mint, 1.5oz Bottle and Tube, Sample Bag |
| 00858290006758 - FluoriMax 2.5% NaF Varnish | 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Bubble Gum |