| Primary Device ID | D8453003102 |
| NIH Device Record Key | 473ec03c-830c-4699-b944-5c042eb08a2e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Laminated Bite Wafers-Wax |
| Version Model Number | 3003102 |
| Catalog Number | 3003102 |
| 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 | false |
| 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 | D8453003102 [Primary] |
| EGD | Wax, Dental, Intraoral |
| 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 |
| D8451112100 - DP-Tray-R | 2021-09-29 DP-Tray-R. Liquid for Premium Tray, 240 ml |
| D8451112200 - DP-Tray-R | 2021-09-29 DP-Tray-R, Liquid Regular, 1 l |
| D8451121112 - Premium Tray | 2021-09-29 Cold-cured acrylic resin, White, 454 g |
| D8451121113 - Premium Tray | 2021-09-29 Cold-cured acrylic resin, Yellow, 454 g |
| D8451121114 - Premium Tray | 2021-09-29 Cold-cured acrylic resin, Pink, 454 g |
| D8451121115 - Premium Tray | 2021-09-29 Cold-cured acrylic resin, Blue, 454 g |
| D8451121212 - Premium Tray | 2021-09-29 Cold-cured acrylic resin, White, 2.3 kg |
| D8451121213 - Premium Tray | 2021-09-29 Cold-cured acrylic resin, Yellow, 2.3 kg |