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FDA 510(k)

MIZZY EXPRESS

K-Number: K093380 · 2010-03-05

ApplicantMycone Dental Supply Co., Inc.
Decision Date2010-03-05
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MIZZY EXPRESS is the device name listed in this FDA 510(k) record. The listed applicant is Mycone Dental Supply Co., Inc.. It received FDA 510(k) clearance on 2010-03-05 under 510(k) number K093380. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIZZY EXPRESS?

MIZZY EXPRESS is a medical device that received FDA 510(k) clearance on 2010-03-05. The listed applicant is Mycone Dental Supply Co., Inc.. The 510(k) number is K093380.

When did MIZZY EXPRESS receive FDA 510(k) clearance?

MIZZY EXPRESS received FDA 510(k) clearance on 2010-03-05, under 510(k) number K093380.

Who is the listed applicant for MIZZY EXPRESS?

The FDA 510(k) record lists Mycone Dental Supply Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIZZY EXPRESS?

The FDA product code for MIZZY EXPRESS is EBG.

Related Clinical Trials

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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Other records listing Mycone Dental Supply Co., 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.

K112597SEITY 37% PHOSPHORIC ACID ETCHANT GELK032773DIAMOND D HIGH IMPACT DENTURE ACRYLIC

Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.

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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