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FDA 510(k)

HY-BOND RESIGLASS

K-Number: K111855 · 2011-11-17

ApplicantShofu Dental Corp.
Decision Date2011-11-17
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HY-BOND RESIGLASS is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corp.. It received FDA 510(k) clearance on 2011-11-17 under 510(k) number K111855. 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 HY-BOND RESIGLASS?

HY-BOND RESIGLASS is a medical device that received FDA 510(k) clearance on 2011-11-17. The listed applicant is Shofu Dental Corp.. The 510(k) number is K111855.

When did HY-BOND RESIGLASS receive FDA 510(k) clearance?

HY-BOND RESIGLASS received FDA 510(k) clearance on 2011-11-17, under 510(k) number K111855.

Who is the listed applicant for HY-BOND RESIGLASS?

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

What is the FDA product code for HY-BOND RESIGLASS?

The FDA product code for HY-BOND RESIGLASS is EMA.

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Other records listing Shofu Dental Corp. as applicant

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K110235BEAUTIBOND MULTIK110252BEAUTIBOND MULTI PR PLUSK101621LITE ARTK101603BEAUTIFIL FLOW PLUSK093559VINTAGE MPK082744BEAUTIBOND

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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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