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FDA 510(k)

DUOLINK II

K-Number: K101787 · 2010-10-08

ApplicantBisco, Inc.
Decision Date2010-10-08
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DUOLINK II is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2010-10-08 under 510(k) number K101787. 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 DUOLINK II?

DUOLINK II is a medical device that received FDA 510(k) clearance on 2010-10-08. The listed applicant is Bisco, Inc.. The 510(k) number is K101787.

When did DUOLINK II receive FDA 510(k) clearance?

DUOLINK II received FDA 510(k) clearance on 2010-10-08, under 510(k) number K101787.

Who is the listed applicant for DUOLINK II?

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

What is the FDA product code for DUOLINK II?

The FDA product code for DUOLINK II is EMA.

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Other records listing Bisco, Inc. 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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