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FDA 510(k)

BIOMER(R) F COMPOSITE LUTING CEMENT

K-Number: K896340 · 1990-05-15

ApplicantDentsply Intl.
Decision Date1990-05-15
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOMER(R) F COMPOSITE LUTING CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1990-05-15 under 510(k) number K896340. 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 BIOMER(R) F COMPOSITE LUTING CEMENT?

BIOMER(R) F COMPOSITE LUTING CEMENT is a medical device that received FDA 510(k) clearance on 1990-05-15. The listed applicant is Dentsply Intl.. The 510(k) number is K896340.

When did BIOMER(R) F COMPOSITE LUTING CEMENT receive FDA 510(k) clearance?

BIOMER(R) F COMPOSITE LUTING CEMENT received FDA 510(k) clearance on 1990-05-15, under 510(k) number K896340.

Who is the listed applicant for BIOMER(R) F COMPOSITE LUTING CEMENT?

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

What is the FDA product code for BIOMER(R) F COMPOSITE LUTING CEMENT?

The FDA product code for BIOMER(R) F 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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