CURA-Temp— 510(k) K202965

Substantially Equivalent

Mgnewton , Ltd.

FDA 510(k) clearance K202965 for CURA-Temp, Substantially Equivalent on 2022-12-21. Applicant: Mgnewton , Ltd.. Device class: 2.

Clearance details

Applicant: Mgnewton , Ltd.
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2020-09-30
Decision date: 2022-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gyeongsan-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBG

K261261 — Dura-Arch2026-04-17
K253380 — FLNT Base and FLNT Temp2026-03-02
K251271 — TempFIT Temporary Crown and Bridge Resin2025-06-23
K243370 — DentaTOOTH2025-05-05
K243621 — Evoblock, Perléon2025-04-22

More clearances from Mgnewton , Ltd.

K202963 — ELEC Master, ELEC Master Dual2023-05-05

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