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FDA 510(k)

NEXADENT (DENTAL CEMENT)

K-Number: K870209 · 1987-02-19

ApplicantBionexus, Inc.
Decision Date1987-02-19
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NEXADENT (DENTAL CEMENT) is the device name listed in this FDA 510(k) record. The listed applicant is Bionexus, Inc.. It received FDA 510(k) clearance on 1987-02-19 under 510(k) number K870209. 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 NEXADENT (DENTAL CEMENT)?

NEXADENT (DENTAL CEMENT) is a medical device that received FDA 510(k) clearance on 1987-02-19. The listed applicant is Bionexus, Inc.. The 510(k) number is K870209.

When did NEXADENT (DENTAL CEMENT) receive FDA 510(k) clearance?

NEXADENT (DENTAL CEMENT) received FDA 510(k) clearance on 1987-02-19, under 510(k) number K870209.

Who is the listed applicant for NEXADENT (DENTAL CEMENT)?

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

What is the FDA product code for NEXADENT (DENTAL CEMENT)?

The FDA product code for NEXADENT (DENTAL CEMENT) is EMA.

Related Clinical Trials

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.

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Other records listing Bionexus, Inc. as applicant

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.

K844173FEMTEST

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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