| Primary Device ID | D815OPAFILL4DO0 |
| NIH Device Record Key | d229c99d-2ceb-44db-91e8-3db66f9a3ecf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPA |
| Version Model Number | OPAFILL4DO |
| Catalog Number | OPAFILL4DO |
| Company DUNS | 053308044 |
| Company Name | OPA DENTAL LLC |
| 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 |
|---|---|
| HIBCC | D815OPAFILL4DO0 [Primary] |
| EBF | Material, Tooth Shade, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-22 |
| Device Publish Date | 2023-12-14 |
| D815OPAFLOW2W0 | Composite Restorative Flowable 2g W |
| D815OPAFLOW2P20 | Composite Restorative Flowable 2g P2 |
| D815OPAFLOW2P10 | Composite Restorative Flowable 2g P1 |
| D815OPAFLOW2LT0 | Composite Restorative Flowable 2g LT |
| D815OPAFLOW2LR0 | Composite Restorative Flowable 2g LR |
| D815OPAFLOW2DR0 | Composite Restorative Flowable 2g DR |
| D815OPAFLOW2DO0 | Composite Restorative Flowable 2g DO |
| D815OPAFILL4P20 | Universal Composite Restorative 4g P2 |
| D815OPAFILL4DR0 | Universal Composite Restorative 4g DR |
| D815OPAFILL4DO0 | Universal Composite Restorative 4g DO |