| Primary Device ID | 07615208453492 |
| NIH Device Record Key | bf017e36-64a1-4587-9db7-ca7b67eb5983 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Helioseal/Clear/F/F Plus |
| Version Model Number | 686771AN |
| Catalog Number | 686771AN |
| Company DUNS | 448015938 |
| Company Name | IVOCLAR VIVADENT AKTIENGESELLSCHAFT |
| 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 | 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 |
|---|---|
| GS1 | 07615208294194 [Primary] |
| GS1 | 07615208453492 [Package] Contains: 07615208294194 Package: [10 Units] In Commercial Distribution |
| GS1 | 07615208472660 [Unit of Use] |
| HIBCC | DVIV686771AN1 [Previous] |
| 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 | 2024-04-12 |
| Device Publish Date | 2024-04-04 |
| 07615208447071 | Helioseal Clear Refill 1x1.25 g |
| 07615208445572 | Helioseal F Plus Refill 1x1.25g |
| 07615208472653 | Helioseal F Plus Refill 5x1.25g |
| 07615208453492 | Helioseal F Plus Cavifil Refill 50x0.1g |
| 07615208445565 | Helioseal F Plus Refill 1x1g |