| Primary Device ID | 00883205032850 |
| NIH Device Record Key | 152fc811-e00b-44d0-a42a-1890013089f8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MTApex |
| Version Model Number | 4900 |
| Catalog Number | 4900 |
| Company DUNS | 013369913 |
| Company Name | ULTRADENT PRODUCTS, INC. |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00883205032850 [Primary] |
| KIF | RESIN, ROOT CANAL FILLING |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-02 |
| Device Publish Date | 2021-11-24 |
| 00883205042835 - Opalustre | 2026-03-18 Opalustre Kit |
| 00883205044068 - Enamelast | 2026-02-19 Enamelast Vanilla Single Cup 200pk |
| 00883205044075 - Enamelast | 2026-02-19 Enamelast Raspberry Single Cup 200pk |
| 00883205044082 - Enamelast | 2026-02-19 Enamelast Flavor Free Single Cup 200pk |
| 00883205044099 - Enamelast | 2026-02-19 Enamelast Cool Mint Single Cup 200pk |
| 00883205044105 - Enamelast | 2026-02-19 Enamelast Walterberry Single Cup 200pk |
| 00883205044112 - Enamelast | 2026-02-19 Enamelast Orange Cream Single Cup 200pk |
| 00883205044129 - Enamelast | 2026-02-19 Enamelast Bubble Gum Single Cup 200pk |