| Primary Device ID | 00810118106620 |
| NIH Device Record Key | 0f220710-436c-4251-b6fc-924597965431 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EdgeEndo Biocermaic Sealer Tip |
| Version Model Number | NEOPROT |
| 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 | true |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810118106620 [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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| 00810118105562 - Ultradent MTApex 5.0 ml Gel | 2026-01-22 Ultradent MTApex 5.0 ml Gel |
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