| Primary Device ID | 10859787002045 |
| NIH Device Record Key | 9cddb7c4-837d-42ed-91d0-9a3bb9fe49ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hemaseal & Cide - Unidose |
| Version Model Number | 180 |
| Company DUNS | 607859147 |
| Company Name | ADVANTAGE DENTAL PRODUCTS INC |
| Device Count | 50 |
| 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 |
| Phone | 248-391-1625 |
| contact@advantagedentalinc.com |
| Total Volume | 0.1 Milliliter |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859787002048 [Primary] |
| GS1 | 00859787002130 [Unit of Use] |
| GS1 | 10859787002045 [Package] Contains: 00859787002048 Package: Case [12 Units] In Commercial Distribution |
| LBH | Varnish, Cavity |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2016-09-16 |
| 10859787002007 - Hemaseal & Cide | 2019-02-07 10mL bottle - dental desensitizer with 4% chlorhexadine |
| 10859787002045 - Hemaseal & Cide - Unidose | 2019-02-0750 single dose dispensers / 0.1mL each dental desensitizer with 4% chlorhexadine |
| 10859787002045 - Hemaseal & Cide - Unidose | 2019-02-07 50 single dose dispensers / 0.1mL each dental desensitizer with 4% chlorhexadine |
| 10859787002014 - MatrixTemp Temporary Crown and Bridge Material | 2018-03-29 Self-cure resin based impression material for the fabrication of temporary crowns and bridges |
| 10859787002021 - MatrixTemp Temporary Crown and Bridge Material | 2018-03-29 Self-cure resin based impression material for the fabrication of temporary crowns and bridges |
| 10859787002038 - MatrixTemp Temporary Crown and Bridge Materail | 2018-03-29 Self-cure resin based impression material for the fabrication of temporary crowns and bridges |
| 10859787002052 - Temporary Crown Matrix Buttons | 2018-03-29 Thermoplastic disk used to make custom temporary crown and bridge restorations |
| 10859787002069 - ThermTray1 Quadrant UL-LR | 2018-03-29 Disposable tray with pre-inserted thermoplastic bite wafer used for dental impressions in conjunction with final impression mate |
| 10859787002076 - ThermTray1 Quadrant UR-LL | 2018-03-29 Disposable tray with pre-inserted thermoplastic bite wafer used for dental impressions in conjunction with final impression mate |