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FDA 510(k)

ESPE CAPMIX

K-Number: K891064 · 1989-05-30

ApplicantEspe GmbH (Us)
Decision Date1989-05-30
Product CodeEFD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ESPE CAPMIX 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 1989-05-30 under 510(k) number K891064. The device is classified under product code EFD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESPE CAPMIX?

ESPE CAPMIX is a medical device that received FDA 510(k) clearance on 1989-05-30. The listed applicant is Espe GmbH (Us). The 510(k) number is K891064.

When did ESPE CAPMIX receive FDA 510(k) clearance?

ESPE CAPMIX received FDA 510(k) clearance on 1989-05-30, under 510(k) number K891064.

Who is the listed applicant for ESPE CAPMIX?

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 ESPE CAPMIX?

The FDA product code for ESPE CAPMIX is EFD.

Related Clinical Trials

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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: EFD)

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.

K991913PENTAMIX 2Espe Dental AGK923974SILIMAT PLUSIvoclar North America, Inc.K922203IPT CAPSULE MIXERIpt Technologies, Inc.K915847AUTOMIX DENTAL AMALGAMATORKerr Corporation (Danbury)K914341MIXOMAT AMALGAMATORDegussa AGK914340DUOMAT 3 AMALGAMATORDegussa 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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