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)

SAVEDENT BLUE

K-Number: K042196 · 2004-11-01

ApplicantDenfotex Light Systems, Ltd.
Decision Date2004-11-01
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SAVEDENT BLUE is the device name listed in this FDA 510(k) record. The listed applicant is Denfotex Light Systems, Ltd.. It received FDA 510(k) clearance on 2004-11-01 under 510(k) number K042196. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAVEDENT BLUE?

SAVEDENT BLUE is a medical device that received FDA 510(k) clearance on 2004-11-01. The listed applicant is Denfotex Light Systems, Ltd.. The 510(k) number is K042196.

When did SAVEDENT BLUE receive FDA 510(k) clearance?

SAVEDENT BLUE received FDA 510(k) clearance on 2004-11-01, under 510(k) number K042196.

Who is the listed applicant for SAVEDENT BLUE?

The FDA 510(k) record lists Denfotex Light Systems, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAVEDENT BLUE?

The FDA product code for SAVEDENT BLUE is EBZ.

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

Related Devices (Code: EBZ)

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.

K253131Curing Light (M-Cure 6)Guangzhou Rebornendo Medical Instrument Co., Ltd.K253461Demi ProMeta Systems Co., Ltd.K242386BluemoonGenoss Co., Ltd.K243921LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd.K250009LED Curing Light (C01-X, C02-X)Premium Plus (Dongguan) LimitedK241238LOOP™ LED Curing Light System (CLK01)Garrison Dental Solutions, LLC

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.

↑