| 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 |
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| 00883205031730 - Opalpix | 2025-03-20 Opalpix 32ct., 100pk |
| 00883205037558 - Ease-In-Shields | 2025-03-20 CO2 Ease-In-Shields OT Light Scalpel |
| 00883205032249 - Chromaclone | 2025-03-19 Chromaclone PVS Heavy Regular Set Refill |
| 00883205032256 - Chromaclone | 2025-03-19 Chromaclone PVS Heavy Fast Set Refill |
| 00883205032263 - Chromaclone | 2025-03-19 Chromaclone PVS Heavy Regular Set Econo Refill |
| 00883205032270 - Chromaclone | 2025-03-19 Chromaclone PVS Heavy Fast Set Econo Refill |
| 00883205032287 - Chromaclone | 2025-03-19 Chromaclone PVS Medium Regular Set Refill |