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FDA 510(k)

SELF ADHESIVE COMPOSITE LUTING CEMENT

K-Number: K093338 · 2010-02-12

ApplicantDmg USA, Inc.
Decision Date2010-02-12
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SELF ADHESIVE COMPOSITE LUTING CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Dmg USA, Inc.. It received FDA 510(k) clearance on 2010-02-12 under 510(k) number K093338. 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 SELF ADHESIVE COMPOSITE LUTING CEMENT?

SELF ADHESIVE COMPOSITE LUTING CEMENT is a medical device that received FDA 510(k) clearance on 2010-02-12. The listed applicant is Dmg USA, Inc.. The 510(k) number is K093338.

When did SELF ADHESIVE COMPOSITE LUTING CEMENT receive FDA 510(k) clearance?

SELF ADHESIVE COMPOSITE LUTING CEMENT received FDA 510(k) clearance on 2010-02-12, under 510(k) number K093338.

Who is the listed applicant for SELF ADHESIVE COMPOSITE LUTING CEMENT?

The FDA 510(k) record lists Dmg USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SELF ADHESIVE COMPOSITE LUTING CEMENT?

The FDA product code for SELF ADHESIVE COMPOSITE LUTING CEMENT 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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