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)

SET

K-Number: K051008 · 2005-06-15

ApplicantSouthern Dental Industries, Ltd.
Decision Date2005-06-15
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SET is the device name listed in this FDA 510(k) record. The listed applicant is Southern Dental Industries, Ltd.. It received FDA 510(k) clearance on 2005-06-15 under 510(k) number K051008. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SET?

SET is a medical device that received FDA 510(k) clearance on 2005-06-15. The listed applicant is Southern Dental Industries, Ltd.. The 510(k) number is K051008.

When did SET receive FDA 510(k) clearance?

SET received FDA 510(k) clearance on 2005-06-15, under 510(k) number K051008.

Who is the listed applicant for SET?

The FDA 510(k) record lists Southern Dental Industries, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SET?

The FDA product code for SET is EMA.

Related PubMed Literature

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.

PMID: 37794720Initial interactions with the FDA on developing a validation dataset as a medical device development tool.The Journal of pathology ()PMID: 36794571Propensity score-based methods for causal inference and external data leveraging in regulatory settings: From basic ideas to implementation.Pharmaceutical statistics ()PMID: 34881099A Pathologist-Annotated Dataset for Validating Artificial Intelligence: A Project Description and Pilot Study.Journal of pathology informatics ()PMID: 34857221Comparative study of a novel portable indirect calorimeter to a reference breath-by-breath instrument and its use in telemedicine settings.Clinical nutrition ESPEN ()

Other records listing Southern Dental Industries, Ltd. 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.

K012528ICEK012529ROK

Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

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.

↑