ArgenZ MTZ
510(k) K242458
ArgenZ MTZ is a Class II device made by Argen Corporation, cleared under FDA 510(k) K242458 on 24 Oct 2024, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK242458 | Date24 Oct 2024 | StatusActive |
Official records
- FDA 510(k) database K242458
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EIH
- Device class
- Class II
- Regulation
- 21 CFR Part 872.6660
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K242458
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ArgenZ GT 98x12 A1 137839 | 137839 / 137839 | D818137839 | — | On the market |
| ArgenZ GT 98x12 A2 137840 | 137840 / 137840 | D818137840 | — | On the market |
| ArgenZ GT 98x12 A3 137841 | 137841 / 137841 | D818137841 | — | On the market |
| ArgenZ GT 98x12 B1 137874 | 137874 / 137874 | D818137874 | — | On the market |
| ArgenZ GT 98x12 B4 137877 | 137877 / 137877 | D818137877 | — | On the market |
| ArgenZ GT 98x12 C1 137902 | 137902 / 137902 | D818137902 | — | On the market |
| ArgenZ GT 98x12 D2 137930 | 137930 / 137930 | D818137930 | — | On the market |
| ArgenZ GT 98x12 OM3 137953 | 137953 / 137953 | D818137953 | — | On the market |
| ArgenZ GT 98x16 A1 137849 | 137849 / 137849 | D818137849 | — | On the market |
| ArgenZ GT 98x16 A2 137850 | 137850 / 137850 | D818137850 | — | On the market |
| ArgenZ GT 98x16 A3 137851 | 137851 / 137851 | D818137851 | — | On the market |
| ArgenZ GT 98x16 B1 137882 | 137882 / 137882 | D818137882 | — | On the market |
| ArgenZ GT 98x16 B4 137885 | 137885 / 137885 | D818137885 | — | On the market |
| ArgenZ GT 98x16 C1 137910 | 137910 / 137910 | D818137910 | — | On the market |
| ArgenZ GT 98x16 D2 137936 | 137936 / 137936 | D818137936 | — | On the market |
| ArgenZ GT 98x16 OM3 137959 | 137959 / 137959 | D818137959 | — | On the market |
| ArgenZ GT 98x20 A1 137859 | 137859 / 137859 | D818137859 | — | On the market |
| ArgenZ GT 98x20 A2 137860 | 137860 / 137860 | D818137860 | — | On the market |
| ArgenZ GT 98x20 A3 137861 | 137861 / 137861 | D818137861 | — | On the market |
| ArgenZ GT 98x20 B1 137890 | 137890 / 137890 | D818137890 | — | On the market |
| ArgenZ GT 98x20 B4 137893 | 137893 / 137893 | D818137893 | — | On the market |
| ArgenZ GT 98x20 C1 137918 | 137918 / 137918 | D818137918 | — | On the market |
| ArgenZ GT 98x20 D2 137942 | 137942 / 137942 | D818137942 | — | On the market |
| ArgenZ GT 98x20 OM3 137965 | 137965 / 137965 | D818137965 | — | On the market |
| ArgenZ GT 98x25 A1 137864 | 137864 / 137864 | D818137864 | — | On the market |
| ArgenZ GT 98x25 A2 137865 | 137865 / 137865 | D818137865 | — | On the market |
| ArgenZ GT 98x25 A3 137866 | 137866 / 137866 | D818137866 | — | On the market |
| ArgenZ GT 98x25 B1 137894 | 137894 / 137894 | D818137894 | — | On the market |
| ArgenZ GT 98x25 B4 137897 | 137897 / 137897 | D818137897 | — | On the market |
| ArgenZ GT 98x25 C1 137922 | 137922 / 137922 | D818137922 | — | On the market |
| ArgenZ GT 98x25 D2 137945 | 137945 / 137945 | D818137945 | — | On the market |
| ArgenZ GT 98x25 OM3 137968 | 137968 / 137968 | D818137968 | — | On the market |
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