Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DUOMAT 3 AMALGAMATOR

K-Number: K914340 · 1991-11-13

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

Device Summary

DUOMAT 3 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 K914340. 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 DUOMAT 3 AMALGAMATOR?

DUOMAT 3 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 K914340.

When did DUOMAT 3 AMALGAMATOR receive FDA 510(k) clearance?

DUOMAT 3 AMALGAMATOR received FDA 510(k) clearance on 1991-11-13, under 510(k) number K914340.

Who is the listed applicant for DUOMAT 3 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 DUOMAT 3 AMALGAMATOR?

The FDA product code for DUOMAT 3 AMALGAMATOR is EFD.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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)K914341MIXOMAT 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.

↑