FDA 510(k)

Riva Cem Automix

K-Number: K214118 · 2022-08-30

Decision Date2022-08-30

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Riva Cem Automix is the device name listed in this FDA 510(k) record. The listed applicant is Sdi Limited. It received FDA 510(k) clearance on 2022-08-30 under 510(k) 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. The listed applicant is Sdi Limited. The 510(k) number is K214118.

When did Riva Cem Automix receive FDA 510(k) clearance?

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

Who is the listed applicant for Riva Cem Automix?

The FDA 510(k) record lists Sdi Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Riva Cem Automix?

The FDA product code for Riva Cem Automix is EMA.

Other records listing Sdi Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222583Stela Capsule System K222581Stela Automix System K191656Zipbond K172047Riva Star

Related Devices (Code: EMA)

K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-Pak K261166DIA-CEMDiaDent Group International K254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.K252606Bifix Veneer LC, Bifix Veneer Try-InVoco GmbH

Official Source

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