| Primary Device ID | DVIV695568WW0 |
| NIH Device Record Key | 9453f740-44c5-4acb-ae8e-37e3d7482a02 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OptraGate Test Pack |
| Version Model Number | 695568WW |
| Catalog Number | 695568WW |
| Company DUNS | 448015938 |
| Company Name | IVOCLAR VIVADENT AKTIENGESELLSCHAFT |
| Device Count | 4 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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 |
|---|---|
| HIBCC | DVIV695568WW0 [Unit of Use] |
| HIBCC | DVIV695568WW1 [Primary] |
| EIF | ACCESSORIES, RETRACTOR, DENTAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-19 |
| Device Publish Date | 2021-04-09 |
| 07615208472707 - OptraGloss | 2025-05-28 OptraGloss Refill Spiral Wheel HP |
| 07615208292824 - OptraGloss | 2025-05-28 OptraGloss Composite Kit |
| 07615208471199 - Politip P / Politip F | 2025-05-28 Politip-F (D) Refill 6 |
| 07615208471182 - Politip P / Politip F | 2025-05-28 Politip-F (C) Refill 6 |
| 07615208471175 - Politip P / Politip F | 2025-05-28 Politip-F (B) Refill 6 |
| 07615208471168 - Politip P / Politip F | 2025-05-28 Politip-P (D) Refill 6 |
| 07615208471151 - Politip P / Politip F | 2025-05-28 Politip-P (C) Refill 6 |
| 07615208469042 - Politip P / Politip F | 2025-05-28 Politip-P (B) Refill 6 |