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FDA 510(k)

ESTELITE SIGMA QUICK

K-Number: K080940 · 2008-06-19

ApplicantTokuyama Dental Corporation
Decision Date2008-06-19
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ESTELITE SIGMA 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 2008-06-19 under 510(k) number K080940. 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 SIGMA QUICK?

ESTELITE SIGMA QUICK is a medical device that received FDA 510(k) clearance on 2008-06-19. The listed applicant is Tokuyama Dental Corporation. The 510(k) number is K080940.

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

ESTELITE SIGMA QUICK received FDA 510(k) clearance on 2008-06-19, under 510(k) number K080940.

Who is the listed applicant for ESTELITE SIGMA 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 SIGMA QUICK?

The FDA product code for ESTELITE SIGMA 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.

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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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