Company ยท KR
DiaDent Group International
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2026. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (6 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 16, 2026 | K254152 | Dia-X Sil Light Body DiaDent Group International, KR | ELW |
| Sep 16, 2026 | K254142 | Dia-X Sil Heavy Body DiaDent Group International, KR | ELW |
| Jul 9, 2026 | K261166 | DIA-CEM DiaDent Group International, KR | EMA |
| Jun 2, 2026 | K261093 | DIAFIL DiaDent Group International, KR | EBF |
| May 19, 2026 | K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) DiaDent Group International, KR | EBF |
| Mar 19, 2026 | K254112 | Dia-X Sil Bite DiaDent Group International, KR | ELW |
| Jul 28, 2023 | K231552 | Dia-Cem DiaDent Group International, KR | EMA |
| Jun 15, 2022 | K220804 | Dia-X Bond Universal DiaDent Group International, KR | KLE |
| Jan 31, 2022 | K213401 | DIAPLUS Universal DiaDent Group International, KR | KLE |
| Jun 28, 2021 | K210421 | Diafil & Diafil Capsule DiaDent Group International, KR | EBF |
| Mar 25, 2021 | K210333 | DiaPaste DiaDent Group International, KR | KIF |
| Sep 18, 2020 | K200174 | DIA-ROOT BIO MTA DiaDent Group International, KR | KIF |
| Aug 7, 2020 | K200809 | D-LUX+ DiaDent Group International, KR | EBZ |
| Jun 25, 2020 | K200175 | DIA-ROOT BIO Sealer DiaDent Group International, KR | KIF |
| May 26, 2020 | K192392 | DiaPlus DiaDent Group International, KR | KLE |
| Mar 27, 2020 | K190091 | Diapaste DiaDent Group International, KR | KIF |
| Mar 25, 2020 | K192284 | DiaFil Flow DiaDent Group International, KR | EBF |
| Mar 20, 2020 | K192510 | DIAFIL & DIAFIL Capsule DiaDent Group International, KR | EBF |
| Feb 13, 2020 | K192158 | DiaTemp DiaDent Group International, KR | EBG |
| Feb 13, 2020 | K192022 | DiaTemp Flow DiaDent Group International, KR | EBG |
| Feb 7, 2020 | K192273 | DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit DiaDent Group International, KR | KLE |
| Sep 26, 2019 | K182009 | Dia-Proseal DiaDent Group International, KR | KIF |
| Jun 3, 2019 | K182625 | Diapex Plus DiaDent Group International, KR | KIF |
| Aug 16, 2013 | K130163 | D-LUX DiaDent Group International, KR | EBZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||