| Primary Device ID | 07615208447071 |
| NIH Device Record Key | dc8e4e1f-b358-413b-98cb-bec2e764c222 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Helioseal/Clear/F/F Plus |
| Version Model Number | 558521AN |
| Catalog Number | 558521AN |
| Company DUNS | 448015938 |
| Company Name | IVOCLAR VIVADENT AKTIENGESELLSCHAFT |
| 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 | 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 | 07615208301335 [Primary] |
| GS1 | 07615208447071 [Package] Contains: 07615208301335 Package: [10 Units] In Commercial Distribution |
| HIBCC | DVIV558521AN1 [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 | 2023-04-14 |
| Device Publish Date | 2023-04-06 |
| 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 |