| Primary Device ID | 00810118105555 |
| NIH Device Record Key | 05ba59a9-b801-439c-81dc-f9c78e783206 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ultradent MTApex 5.0 g Powder |
| Version Model Number | 13869 |
| Company DUNS | 185497372 |
| Company Name | NUSMILE, LTD. |
| 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 | 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810118105555 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-22 |
| Device Publish Date | 2026-01-14 |
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| 00810118105555 - Ultradent MTApex 5.0 g Powder | 2026-01-22Ultradent MTApex 5.0 g Powder |
| 00810118105555 - Ultradent MTApex 5.0 g Powder | 2026-01-22 Ultradent MTApex 5.0 g Powder |
| 00810118105562 - Ultradent MTApex 5.0 ml Gel | 2026-01-22 Ultradent MTApex 5.0 ml Gel |
| 00810118106620 - EdgeEndo Biocermaic Sealer Tip | 2026-01-22 EdgeEndo Biocermaic Sealer Tip 15 Pack |
| 00810118106637 - Dentsply ProRoot Flex Tip | 2026-01-22 Dentsply ProRoot Flex Tip 20 Pack |
| 00810118106644 - NuSmile ReVIVE Crowns | 2025-12-04 NuSmile ReVIVE Anterior Pediatric Crowns Starter Kit - 48 Crowns, Light Shade |
| 00810118106651 - NuSmile ReVIVE Crowns | 2025-12-04 NuSmile ReVIVE Anterior Pediatric Crowns Professional Kit - 88 Crowns, Light Shade |
| 00810118106682 - NuSmile ReVIVE Crowns | 2025-12-04 NuSmile ReVIVE Regular First and Second Primary Molar - Professional Kit - 80 Crowns, Light Shade |