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FDA 510(k)

LUTE-IT II VENEER CEMENT, MODEL NO6

K-Number: K081887 · 2008-08-29

ApplicantPentron Clinical Technologies
Decision Date2008-08-29
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LUTE-IT II VENEER CEMENT, MODEL NO6 is the device name listed in this FDA 510(k) record. The listed applicant is Pentron Clinical Technologies. It received FDA 510(k) clearance on 2008-08-29 under 510(k) number K081887. 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 LUTE-IT II VENEER CEMENT, MODEL NO6?

LUTE-IT II VENEER CEMENT, MODEL NO6 is a medical device that received FDA 510(k) clearance on 2008-08-29. The listed applicant is Pentron Clinical Technologies. The 510(k) number is K081887.

When did LUTE-IT II VENEER CEMENT, MODEL NO6 receive FDA 510(k) clearance?

LUTE-IT II VENEER CEMENT, MODEL NO6 received FDA 510(k) clearance on 2008-08-29, under 510(k) number K081887.

Who is the listed applicant for LUTE-IT II VENEER CEMENT, MODEL NO6?

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

What is the FDA product code for LUTE-IT II VENEER CEMENT, MODEL NO6?

The FDA product code for LUTE-IT II VENEER CEMENT, MODEL NO6 is EMA.

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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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