Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Riva Cem Automix

K-Number: K214118 · 2022-08-30

ApplicantSdi Limited
Decision Date2022-08-30
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Riva Cem Automix is a medical device manufactured by Sdi Limited. It received FDA 510(k) clearance on 2022-08-30 under approval number K214118. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Riva Cem Automix?

Riva Cem Automix is a medical device that received FDA 510(k) clearance on 2022-08-30. It is manufactured by Sdi Limited. The 510(k) number is K214118.

When was Riva Cem Automix approved by the FDA?

Riva Cem Automix received FDA 510(k) clearance on 2022-08-30, under approval number K214118.

What company makes Riva Cem Automix?

Riva Cem Automix is manufactured by Sdi Limited.

What is the FDA product code for Riva Cem Automix?

The FDA product code for Riva Cem Automix is EMA.

Other Devices by Sdi Limited

K172047Riva Star K191656Zipbond K222583Stela Capsule System K222581Stela Automix System

Related Devices (Code: EMA)

K160800DuoCemColtene/Whaledent AG K161851Glass Ionomer Cement (Luting)Shandong Huge Dental Material Corporation K160443TempoCem ClearDmg USA, Inc. K160774IonoStar PlusVoco GmbH K161256TheraCemBisco, Inc. K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑