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FDA 510(k)

MODIFIED PERMAGUM ADHESIVE

K-Number: K881838 · 1988-07-27

ApplicantEspe GmbH (Us)
Decision Date1988-07-27
Product CodeEBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFIED PERMAGUM ADHESIVE 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 1988-07-27 under 510(k) number K881838. The device is classified under product code EBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED PERMAGUM ADHESIVE?

MODIFIED PERMAGUM ADHESIVE is a medical device that received FDA 510(k) clearance on 1988-07-27. The listed applicant is Espe GmbH (Us). The 510(k) number is K881838.

When did MODIFIED PERMAGUM ADHESIVE receive FDA 510(k) clearance?

MODIFIED PERMAGUM ADHESIVE received FDA 510(k) clearance on 1988-07-27, under 510(k) number K881838.

Who is the listed applicant for MODIFIED PERMAGUM ADHESIVE?

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 PERMAGUM ADHESIVE?

The FDA product code for MODIFIED PERMAGUM ADHESIVE is EBH.

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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: EBH)

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.

K933745PERMAGEN UNIVERSAL BONDING RESINBio-Systems ResearchK930487PALATRAY LC MINTHeraeus Kulzer, Inc.K923979LC TRAY MATERIALDentsply Intl.K923549PALADISC LCHeraeus Kulzer, Inc.K912820POLYESTER RESIN HAND MOLDED TRAYE&D Dental Products, Inc.K905058PALAVIT LKulzer, Inc.

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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