| Primary Device ID | D8451121112 |
| NIH Device Record Key | 10fc5f50-6fcc-49e6-830d-0b8fe7460f59 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Premium Tray |
| Version Model Number | 1121112 |
| Catalog Number | 1121112 |
| Company DUNS | 202016064 |
| Company Name | Denplus Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D8451121112 [Primary] |
| EBH | Material, Impression Tray, 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 | 2021-09-29 |
| Device Publish Date | 2021-09-21 |
| D8451121315 | Cold-Cured Acrylic Resin, Blue, 11.3 kg |
| D8451121314 | Cold-cured acrylic resin, Pink, 11.3 kg |
| D8451121313 | Cold-cured acrylic resin, Yellow, 11.3 kg |
| D8451121312 | Cold-cured acrylic resin, White, 11.3 kg |
| D8451121215 | Cold-cured acrylic resin, Blue, 2.3 kg |
| D8451121214 | Cold-cured acrylic resin, Pink, 2.3 kg |
| D8451121213 | Cold-cured acrylic resin, Yellow, 2.3 kg |
| D8451121212 | Cold-cured acrylic resin, White, 2.3 kg |
| D8451121115 | Cold-cured acrylic resin, Blue, 454 g |
| D8451121114 | Cold-cured acrylic resin, Pink, 454 g |
| D8451121113 | Cold-cured acrylic resin, Yellow, 454 g |
| D8451121112 | Cold-cured acrylic resin, White, 454 g |