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)

MD-Temp Plus

K-Number: K190724 · 2019-07-03

ApplicantMeta Biomed Co., Ltd.
Decision Date2019-07-03
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MD-Temp Plus is the device name listed in this FDA 510(k) record. The listed applicant is Meta Biomed Co., Ltd.. It received FDA 510(k) clearance on 2019-07-03 under 510(k) number K190724. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MD-Temp Plus?

MD-Temp Plus is a medical device that received FDA 510(k) clearance on 2019-07-03. The listed applicant is Meta Biomed Co., Ltd.. The 510(k) number is K190724.

When did MD-Temp Plus receive FDA 510(k) clearance?

MD-Temp Plus received FDA 510(k) clearance on 2019-07-03, under 510(k) number K190724.

Who is the listed applicant for MD-Temp Plus?

The FDA 510(k) record lists Meta Biomed Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MD-Temp Plus?

The FDA product code for MD-Temp Plus is EBG.

Other records listing Meta Biomed Co., 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.

K242014Jet Flow BulkK232299CeraPuttyK230010ADSEAL PlusK230009EZ Bond UniversalK210904Metapaste PlusK202617Metapex Plus

View all 13 devices →

Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.

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.

↑