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FDA 510(k)

DIA-CEM

K-Number: K261166 · 2026-07-09

ApplicantDiaDent Group International
Decision Date2026-07-09
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIA-CEM is the device name listed in this FDA 510(k) record. The listed applicant is DiaDent Group International. It received FDA 510(k) clearance on 2026-07-09 under 510(k) number K261166. 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 DIA-CEM?

DIA-CEM is a medical device that received FDA 510(k) clearance on 2026-07-09. The listed applicant is DiaDent Group International. The 510(k) number is K261166.

When did DIA-CEM receive FDA 510(k) clearance?

DIA-CEM received FDA 510(k) clearance on 2026-07-09, under 510(k) number K261166.

Who is the listed applicant for DIA-CEM?

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

What is the FDA product code for DIA-CEM?

The FDA product code for DIA-CEM is EMA.

Other records listing DiaDent Group International 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.

K261093DIAFILK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)K254112Dia-X Sil BiteK231552Dia-CemK220804Dia-X Bond UniversalK213401DIAPLUS Universal

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Related Devices (Code: EMA)

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.

K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.K252606Bifix Veneer LC, Bifix Veneer Try-InVoco GmbHK254063iCEM Universal PlusKulzer, LLC

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.

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