DiaDent Group International
FDA 510(k) & PMA Approved Devices — 21 products
Total Devices21
Categories7
Latest FDA decision2026-07-09
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K261166 | DIA-CEM | EMA | 2026-07-09 | View |
| 510(k) | K261093 | DIAFIL | EBF | 2026-06-02 | View |
| 510(k) | K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) | EBF | 2026-05-19 | View |
| 510(k) | K254112 | Dia-X Sil Bite | ELW | 2026-03-19 | View |
| 510(k) | K231552 | Dia-Cem | EMA | 2023-07-28 | View |
| 510(k) | K220804 | Dia-X Bond Universal | KLE | 2022-06-15 | View |
| 510(k) | K213401 | DIAPLUS Universal | KLE | 2022-01-31 | View |
| 510(k) | K210421 | Diafil & Diafil Capsule | EBF | 2021-06-28 | View |
| 510(k) | K210333 | DiaPaste | KIF | 2021-03-25 | View |
| 510(k) | K200174 | DIA-ROOT BIO MTA | KIF | 2020-09-18 | View |
| 510(k) | K200809 | D-LUX+ | EBZ | 2020-08-07 | View |
| 510(k) | K200175 | DIA-ROOT BIO Sealer | KIF | 2020-06-25 | View |
| 510(k) | K192392 | DiaPlus | KLE | 2020-05-26 | View |
| 510(k) | K190091 | Diapaste | KIF | 2020-03-27 | View |
| 510(k) | K192284 | DiaFil Flow | EBF | 2020-03-25 | View |
| 510(k) | K192510 | DIAFIL & DIAFIL Capsule | EBF | 2020-03-20 | View |
| 510(k) | K192022 | DiaTemp Flow | EBG | 2020-02-13 | View |
| 510(k) | K192158 | DiaTemp | EBG | 2020-02-13 | View |
| 510(k) | K192273 | DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit | KLE | 2020-02-07 | View |
| 510(k) | K182009 | Dia-Proseal | KIF | 2019-09-26 | View |
No matching devices.
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