| Primary Device ID | 00858290006567 |
| NIH Device Record Key | da5029ef-0a51-4699-aeb3-fa3c8ba69329 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DenteShield Surface Sealant 3ml Kit |
| Version Model Number | 685SSB300 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858290006567 [Primary] |
| EBC | Sealant, Pit And Fissure, And Conditioner |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-09 |
| Device Publish Date | 2020-04-01 |
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| 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 |
| 00858290006765 - FluoriMax 2.5% NaF Varnish | 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Mint |
| 00858290006772 - FluoriMax 2.5% NaF Varnish | 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Caramel |
| 00858290006789 - FluoriMax 2.5% NaF Varnish 1 Bottle Kit Unflavored | 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Unflavored |
| 00858290006796 - FluoriMax 2.5% NaF Varnish 1 Bottle Kit Cotton Candy | 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Cotton Candy |