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FDA 510(k)

FOUNDATION DENTAL RESIN

K-Number: K111709 · 2011-11-18

ApplicantUnix-Japan Co., Ltd.
Decision Date2011-11-18
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FOUNDATION DENTAL RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Unix-Japan Co., Ltd.. It received FDA 510(k) clearance on 2011-11-18 under 510(k) number K111709. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOUNDATION DENTAL RESIN?

FOUNDATION DENTAL RESIN is a medical device that received FDA 510(k) clearance on 2011-11-18. The listed applicant is Unix-Japan Co., Ltd.. The 510(k) number is K111709.

When did FOUNDATION DENTAL RESIN receive FDA 510(k) clearance?

FOUNDATION DENTAL RESIN received FDA 510(k) clearance on 2011-11-18, under 510(k) number K111709.

Who is the listed applicant for FOUNDATION DENTAL RESIN?

The FDA 510(k) record lists Unix-Japan Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOUNDATION DENTAL RESIN?

The FDA product code for FOUNDATION DENTAL RESIN is EBI.

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Related Devices (Code: EBI)

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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, 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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