Dia-Cem— 510(k) K231552

Substantially Equivalent

DiaDent Group International

FDA 510(k) clearance K231552 for Dia-Cem, Substantially Equivalent on 2023-07-28. Applicant: DiaDent Group International. Device class: 2.

Clearance details

Applicant: DiaDent Group International
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2023-05-30
Decision date: 2023-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheongju-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code EMA

K254201 — Any-Cem2026-08-13
K261937 — PacTemp Automix NE2026-08-07
K261166 — DIA-CEM2026-07-09
K254109 — G-CEM UNIVERSAL2026-05-18
K253337 — REGEN Bioactive Cement2026-04-15

More clearances from DiaDent Group International

K261093 — DIAFIL2026-06-02
K261071 — DIAFIL Bulk FLOW (3 models)2026-05-19
K254112 — Dia-X Sil Bite2026-03-19
K220804 — Dia-X Bond Universal2022-06-15
K213401 — DIAPLUS Universal2022-01-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.