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FDA 510(k)

RMGI LOW VISCOSITY

K-Number: K123265 · 2012-12-07

ApplicantPulpdent Corporation
Decision Date2012-12-07
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RMGI LOW VISCOSITY is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corporation. It received FDA 510(k) clearance on 2012-12-07 under 510(k) number K123265. 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 RMGI LOW VISCOSITY?

RMGI LOW VISCOSITY is a medical device that received FDA 510(k) clearance on 2012-12-07. The listed applicant is Pulpdent Corporation. The 510(k) number is K123265.

When did RMGI LOW VISCOSITY receive FDA 510(k) clearance?

RMGI LOW VISCOSITY received FDA 510(k) clearance on 2012-12-07, under 510(k) number K123265.

Who is the listed applicant for RMGI LOW VISCOSITY?

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

What is the FDA product code for RMGI LOW VISCOSITY?

The FDA product code for RMGI LOW VISCOSITY is EMA.

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Other records listing Pulpdent Corporation 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.

K262983EsTemp ImplantSpident Co., Ltd.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.

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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