Riva Cem Automix— 510(k) K214118

Substantially Equivalent

Sdi Limited

FDA 510(k) clearance K214118 for Riva Cem Automix, Substantially Equivalent on 2022-08-30. Applicant: Sdi Limited. Device class: 2.

Clearance details

Applicant: Sdi Limited
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2021-12-30
Decision date: 2022-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bayswater, AU

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 Sdi Limited

K222581 — Stela Automix System2022-10-28
K222583 — Stela Capsule System2022-10-28
K191656 — Zipbond2019-12-02
K172047 — Riva Star2018-04-11
K102984 — AURA2010-12-08

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