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FDA 510(k)

UVIOFIL

K-Number: K771327 · 1977-08-02

ApplicantEspe GmbH (Us)
Decision Date1977-08-02
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UVIOFIL is the device name listed in this FDA 510(k) record. The listed applicant is Espe GmbH (Us). It received FDA 510(k) clearance on 1977-08-02 under 510(k) number K771327. 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 UVIOFIL?

UVIOFIL is a medical device that received FDA 510(k) clearance on 1977-08-02. The listed applicant is Espe GmbH (Us). The 510(k) number is K771327.

When did UVIOFIL receive FDA 510(k) clearance?

UVIOFIL received FDA 510(k) clearance on 1977-08-02, under 510(k) number K771327.

Who is the listed applicant for UVIOFIL?

The FDA 510(k) record lists Espe GmbH (Us) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UVIOFIL?

The FDA product code for UVIOFIL is EBC.

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Other records listing Espe GmbH (Us) 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.

K925027PHOTAC-FIL APLICAPK913966SONO(R) -CEMK915005PHOTAC-BOND APLICAP, MODIFICATIONK913857ROCATEC(R) -PLUSK913965ESPE(R) -SILK905604VISIO-GEM ART-SYSTEM

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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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