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)

SUPER 1

K-Number: K002298 · 2000-08-24

ApplicantDental Alloy Products, Inc.
Decision Date2000-08-24
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SUPER 1 is the device name listed in this FDA 510(k) record. The listed applicant is Dental Alloy Products, Inc.. It received FDA 510(k) clearance on 2000-08-24 under 510(k) number K002298. The device is classified under product code EJH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUPER 1?

SUPER 1 is a medical device that received FDA 510(k) clearance on 2000-08-24. The listed applicant is Dental Alloy Products, Inc.. The 510(k) number is K002298.

When did SUPER 1 receive FDA 510(k) clearance?

SUPER 1 received FDA 510(k) clearance on 2000-08-24, under 510(k) number K002298.

Who is the listed applicant for SUPER 1?

The FDA 510(k) record lists Dental Alloy Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUPER 1?

The FDA product code for SUPER 1 is EJH.

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 Dental Alloy Products, Inc. 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.

K002302SUPER 14K002300SUPER 6K002299SUPER 3K002301SUPER 12

Related Devices (Code: EJH)

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.

K123929BEGOPAL+Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & COK040180CONTINUM VAalba Dent, Inc.K040179CONTINUMAalba Dent, Inc.K033356VERASOFT ESAalba Dent, Inc.K033045DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECASTAmerican Green Dent. Mfg, Inc.K032136WIROBOND CBego U.S.A.

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.

↑