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FDA 510(k)

DENTOMAT 3 AMALGAMATORS

K-Number: K914339 · 1991-11-07

ApplicantDegussa AG
Decision Date1991-11-07
Product CodeEFD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTOMAT 3 AMALGAMATORS is the device name listed in this FDA 510(k) record. The listed applicant is Degussa AG. It received FDA 510(k) clearance on 1991-11-07 under 510(k) number K914339. 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 DENTOMAT 3 AMALGAMATORS?

DENTOMAT 3 AMALGAMATORS is a medical device that received FDA 510(k) clearance on 1991-11-07. The listed applicant is Degussa AG. The 510(k) number is K914339.

When did DENTOMAT 3 AMALGAMATORS receive FDA 510(k) clearance?

DENTOMAT 3 AMALGAMATORS received FDA 510(k) clearance on 1991-11-07, under 510(k) number K914339.

Who is the listed applicant for DENTOMAT 3 AMALGAMATORS?

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 DENTOMAT 3 AMALGAMATORS?

The FDA product code for DENTOMAT 3 AMALGAMATORS 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 AGK914341MIXOMAT 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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