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FDA 510(k)

MODIFIED VISIO-SEAL

K-Number: K873069 · 1987-09-15

ApplicantEspe GmbH (Us)
Decision Date1987-09-15
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFIED VISIO-SEAL 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 1987-09-15 under 510(k) number K873069. 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 MODIFIED VISIO-SEAL?

MODIFIED VISIO-SEAL is a medical device that received FDA 510(k) clearance on 1987-09-15. The listed applicant is Espe GmbH (Us). The 510(k) number is K873069.

When did MODIFIED VISIO-SEAL receive FDA 510(k) clearance?

MODIFIED VISIO-SEAL received FDA 510(k) clearance on 1987-09-15, under 510(k) number K873069.

Who is the listed applicant for MODIFIED VISIO-SEAL?

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 MODIFIED VISIO-SEAL?

The FDA product code for MODIFIED VISIO-SEAL 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 APLICAPK915005PHOTAC-BOND APLICAP, MODIFICATIONK913966SONO(R) -CEMK913857ROCATEC(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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