| Primary Device ID | 10304040000875 |
| NIH Device Record Key | 4397e9f1-d167-4170-9e9f-172ce89db4f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Z-Dent Anterior |
| Version Model Number | 2285328 |
| Catalog Number | 2285328 |
| Company DUNS | 012430880 |
| Company Name | HENRY SCHEIN, 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 23 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00304040000878 [Primary] |
| GS1 | 10304040000875 [Package] Contains: 00304040000878 Package: BOX [20 Units] In Commercial Distribution |
| ELM | Denture, plastic, teeth |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
| 00304040194775 - Henry Schein | 2026-02-04 Custom Plastics Pack |
| 00304040194812 - Henry Schein | 2026-02-04 Abdominoplasty Pack |
| 00304040194829 - Henry Schein | 2026-02-04 Basic Pack PSSC002-01 (TBD) |
| 00304040194836 - Henry Schein | 2026-02-04 Breast Pack PSSC003-01 (TBD) |
| 00304040194843 - Henry Schein | 2026-02-04 Head and Neck Pack PSSC004-01 (TBD) |
| 00304040194782 - Henry Schein | 2026-01-28 Essentials Mixing Tips Large |
| 00304040194799 - Henry Schein | 2026-01-28 Essentials Mixing Tips Small |
| 00304040194805 - Henry Schein | 2026-01-28 Essentials Intraoral Tips |