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FDA 510(k)

TOKUYAMA M-BOND

K-Number: K011854 · 2001-09-04

ApplicantTokuyama America, Inc.
Decision Date2001-09-04
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TOKUYAMA M-BOND 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 2001-09-04 under 510(k) number K011854. 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 TOKUYAMA M-BOND?

TOKUYAMA M-BOND is a medical device that received FDA 510(k) clearance on 2001-09-04. The listed applicant is Tokuyama America, Inc.. The 510(k) number is K011854.

When did TOKUYAMA M-BOND receive FDA 510(k) clearance?

TOKUYAMA M-BOND received FDA 510(k) clearance on 2001-09-04, under 510(k) number K011854.

Who is the listed applicant for TOKUYAMA M-BOND?

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 TOKUYAMA M-BOND?

The FDA product code for TOKUYAMA M-BOND 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 IIK011685BISTITE II DCK010267PALFIQUE 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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