| Primary Device ID | 00865849000211 |
| NIH Device Record Key | a916e620-e54f-434b-948e-9dc560e00d22 |
| Commercial Distribution Discontinuation | 2021-01-09 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DDS Dentin Desensitizer System with Fluoride |
| Version Model Number | G6 |
| Company DUNS | 877942011 |
| Company Name | AMERICAN DENTAL PRODUCTS INC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| 00865849000204 - Dentin Desensitizing with Fluoride | 2019-11-11 A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recessio |
| 00865849000242 - Dentin Desensitizer with Fluoride | 2019-05-15 A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recessio |
| 00865849000211 - DDS Dentin Desensitizer System with Fluoride | 2019-02-07A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused. |
| 00865849000211 - DDS Dentin Desensitizer System with Fluoride | 2019-02-07 A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recessio |
| 00865849000228 - Dentin Desensitizer with Fluoride | 2019-02-07 A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recessio |