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FDA 510(k)

MIXOMAT AMALGAMATOR

K-Number: K914341 · 1991-11-13

ApplicantDegussa AG
Decision Date1991-11-13
Product CodeEFD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MIXOMAT AMALGAMATOR is the device name listed in this FDA 510(k) record. The listed applicant is Degussa AG. It received FDA 510(k) clearance on 1991-11-13 under 510(k) number K914341. 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 MIXOMAT AMALGAMATOR?

MIXOMAT AMALGAMATOR is a medical device that received FDA 510(k) clearance on 1991-11-13. The listed applicant is Degussa AG. The 510(k) number is K914341.

When did MIXOMAT AMALGAMATOR receive FDA 510(k) clearance?

MIXOMAT AMALGAMATOR received FDA 510(k) clearance on 1991-11-13, under 510(k) number K914341.

Who is the listed applicant for MIXOMAT AMALGAMATOR?

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

What is the FDA product code for MIXOMAT AMALGAMATOR?

The FDA product code for MIXOMAT AMALGAMATOR is EFD.

Related Clinical Trials

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Other records listing Degussa AG 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.

K953344DEGUBOND ULTRAK931808DUCERAGOLD, DUCERATINK926347DUCERANIUM UK922790DEGUCAST 40K921772BIOLORK921479DUCERATIN/DUCERAM LFC DENTAL PORCELAIN

View all 33 devices →

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)K914340DUOMAT 3 AMALGAMATORDegussa AGK914339DENTOMAT 3 AMALGAMATORSDegussa 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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