| Primary Device ID | 00858290006598 |
| NIH Device Record Key | e8de7312-6ac3-4b4d-8598-97d9b172c12b |
| Commercial Distribution Discontinuation | 2024-12-02 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | DenteShield Sample Opaque with Fluoride |
| Version Model Number | 685DSSAMP |
| Company DUNS | 002863526 |
| Company Name | ELEVATE ORAL CARE, LLC |
| 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 |
|---|---|
| GS1 | 00858290006598 [Primary] |
| EBC | Sealant, Pit And Fissure, And Conditioner |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-12-03 |
| Device Publish Date | 2020-06-11 |
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| 00858290006932 - Povi-One | 2024-12-20 Povi-One/FluoriMax Varnish BG Convenience Bottle Kit - 8ml bottle |
| 00858290006598 - DenteShield Sample Opaque with Fluoride | 2024-12-03DenteShield Sample Opaque with Fluoride |
| 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 |