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FDA 510(k)

QUIKSEAL

K-Number: K923895 · 1992-12-23

ApplicantMirage Dental Systems
Decision Date1992-12-23
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

QUIKSEAL is the device name listed in this FDA 510(k) record. The listed applicant is Mirage Dental Systems. It received FDA 510(k) clearance on 1992-12-23 under 510(k) number K923895. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIKSEAL?

QUIKSEAL is a medical device that received FDA 510(k) clearance on 1992-12-23. The listed applicant is Mirage Dental Systems. The 510(k) number is K923895.

When did QUIKSEAL receive FDA 510(k) clearance?

QUIKSEAL received FDA 510(k) clearance on 1992-12-23, under 510(k) number K923895.

Who is the listed applicant for QUIKSEAL?

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

What is the FDA product code for QUIKSEAL?

The FDA product code for QUIKSEAL is EBC.

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 Mirage Dental Systems 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.

K931845SANDBLASTERK915511MIRAGE COMPLETE KIT AND MIRAGE ABC KIT

Related Devices (Code: EBC)

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.

K260819Any-Com SealMediclus Co., Ltd.K243254Parkell Pit and Fissure SealantParkell, Inc.K232498UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioUltradent Product, Inc.K230455Enamel Coating ResinRizhao Huge Biomaterials Company, Ltd.K190998BA Pit & Fissure SealantApex Dental Materials, Inc.K190339Helioseal F PlusIvoclar Vivadent, AG

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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