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FDA 510(k)

BISTITE II DC

K-Number: K011685 · 2001-07-31

ApplicantTokuyama America, Inc.
Decision Date2001-07-31
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BISTITE II DC is the device name listed in this FDA 510(k) record. The listed applicant is Tokuyama America, Inc.. It received FDA 510(k) clearance on 2001-07-31 under 510(k) number K011685. 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 BISTITE II DC?

BISTITE II DC is a medical device that received FDA 510(k) clearance on 2001-07-31. The listed applicant is Tokuyama America, Inc.. The 510(k) number is K011685.

When did BISTITE II DC receive FDA 510(k) clearance?

BISTITE II DC received FDA 510(k) clearance on 2001-07-31, under 510(k) number K011685.

Who is the listed applicant for BISTITE II DC?

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

What is the FDA product code for BISTITE II DC?

The FDA product code for BISTITE II DC is EMA.

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Other records listing Tokuyama America, 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.

K022641TOKUYAMA REBASE IIK011854TOKUYAMA M-BONDK010267PALFIQUE ESTELITE LV CLEARK002863PALFIQUE ESTELITE LVK993917TOKUYAMA ONE-UP-BOND FK991711BISTITE II SC

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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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