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FDA 510(k)

ESTELITE FLOW QUICK

K-Number: K051808 · 2005-08-08

ApplicantTokuyama Dental Corporation
Decision Date2005-08-08
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ESTELITE FLOW QUICK is the device name listed in this FDA 510(k) record. The listed applicant is Tokuyama Dental Corporation. It received FDA 510(k) clearance on 2005-08-08 under 510(k) number K051808. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESTELITE FLOW QUICK?

ESTELITE FLOW QUICK is a medical device that received FDA 510(k) clearance on 2005-08-08. The listed applicant is Tokuyama Dental Corporation. The 510(k) number is K051808.

When did ESTELITE FLOW QUICK receive FDA 510(k) clearance?

ESTELITE FLOW QUICK received FDA 510(k) clearance on 2005-08-08, under 510(k) number K051808.

Who is the listed applicant for ESTELITE FLOW QUICK?

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

What is the FDA product code for ESTELITE FLOW QUICK?

The FDA product code for ESTELITE FLOW QUICK is EBF.

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Other records listing Tokuyama Dental Corporation 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.

K203760Tokuyama Universal Bond IIK203598Omnichroma Flow BulkK193537Omnichroma FlowK190940Tokuyama Rebase IIIK180613Estelite Universal FlowK173275OMNICHROMA

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Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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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