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FDA 510(k)

RODIN Cement

K-Number: K251775 · 2025-09-02

ApplicantBelport Company, Inc., Gingi-Pak
Decision Date2025-09-02
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RODIN Cement is the device name listed in this FDA 510(k) record. The listed applicant is Belport Company, Inc., Gingi-Pak. It received FDA 510(k) clearance on 2025-09-02 under 510(k) number K251775. 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 RODIN Cement?

RODIN Cement is a medical device that received FDA 510(k) clearance on 2025-09-02. The listed applicant is Belport Company, Inc., Gingi-Pak. The 510(k) number is K251775.

When did RODIN Cement receive FDA 510(k) clearance?

RODIN Cement received FDA 510(k) clearance on 2025-09-02, under 510(k) number K251775.

Who is the listed applicant for RODIN Cement?

The FDA 510(k) record lists Belport Company, Inc., Gingi-Pak as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RODIN Cement?

The FDA product code for RODIN Cement is EMA.

Other records listing Belport Company, Inc., Gingi-Pak as applicant

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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-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.K252606Bifix Veneer LC, Bifix Veneer Try-InVoco GmbH

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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