| Primary Device ID | 00883205103628 |
| NIH Device Record Key | 14015159-e27c-4233-9a1e-833c964d3680 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Silane |
| Version Model Number | 410 |
| Catalog Number | 410 |
| Company DUNS | 013369913 |
| Company Name | ULTRADENT PRODUCTS, INC. |
| 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 | false |
| 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 |
| Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00883205103628 [Primary] |
| EBF | MATERIAL, TOOTH SHADE, RESIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-22 |
| 00883205030177 - White Mac Tip | 2024-12-25 White Mac Tips 10pk |
| 00883205030900 - VALO | 2024-12-25 VALO GRAND SAPPHIRE (Cordless) |
| 00883205030917 - VALO | 2024-12-25 VALO GRAND RED ROCK (CORDLESS) |
| 00883205030924 - VALO | 2024-12-25 VALO GRAND MIDNIGHT (CORDLESS) |
| 00883205031587 - Thermo Clone VPS | 2024-12-25 Thermo Clone VPS Fast Set Superlight Body 2x50 ml Refill Kit |
| 00883205031709 - Thermo Clone | 2024-12-25 Thermo Clone VPS Fast Set Light Body 10x50 ml Bulk Pack |
| 00883205031716 - Thermo Clone | 2024-12-25 Thermo Clone VPS Fast Set Heavy 10x50 ml Bulk Pack |
| 00883205031860 - Gishy Goo | 2024-12-25 Gishy Goo! One-Patient Kit Tooth Color |