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)

LUXATEMP ULTRA /STAR

K-Number: K101710 · 2010-09-28

ApplicantDmg USA, Inc.
Decision Date2010-09-28
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LUXATEMP ULTRA /STAR is the device name listed in this FDA 510(k) record. The listed applicant is Dmg USA, Inc.. It received FDA 510(k) clearance on 2010-09-28 under 510(k) number K101710. 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 LUXATEMP ULTRA /STAR?

LUXATEMP ULTRA /STAR is a medical device that received FDA 510(k) clearance on 2010-09-28. The listed applicant is Dmg USA, Inc.. The 510(k) number is K101710.

When did LUXATEMP ULTRA /STAR receive FDA 510(k) clearance?

LUXATEMP ULTRA /STAR received FDA 510(k) clearance on 2010-09-28, under 510(k) number K101710.

Who is the listed applicant for LUXATEMP ULTRA /STAR?

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

What is the FDA product code for LUXATEMP ULTRA /STAR?

The FDA product code for LUXATEMP ULTRA /STAR is EBG.

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 Dmg USA, 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.

K171772Ecosite Bulk FillK160443TempoCem ClearK110759TEMPOCEMK102603SA FLOWABLE ADHESIVEK100062INFILTRATION KITK093338SELF ADHESIVE COMPOSITE LUTING CEMENT

View all 27 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.

↑