Cleared Traditional

Riva Cem Automix

K214118 · Sdi Limited · Dental
Aug 2022
Decision
243d
Days
Class 2
Risk

About This 510(k) Submission

K214118 is an FDA 510(k) clearance for the Riva Cem Automix, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Sdi Limited (Bayswater, AU). The FDA issued a Cleared decision on August 30, 2022, 243 days after receiving the submission on December 30, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K214118 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2021
Decision Date August 30, 2022
Days to Decision 243 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275