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)

ESTELITE COLOR

K-Number: K110178 · 2011-04-05

ApplicantTokuyama Dental Corporation
Decision Date2011-04-05
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ESTELITE COLOR is the device name listed in this FDA 510(k) record. The listed applicant is Tokuyama Dental Corporation. It received FDA 510(k) clearance on 2011-04-05 under 510(k) number K110178. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESTELITE COLOR?

ESTELITE COLOR is a medical device that received FDA 510(k) clearance on 2011-04-05. The listed applicant is Tokuyama Dental Corporation. The 510(k) number is K110178.

When did ESTELITE COLOR receive FDA 510(k) clearance?

ESTELITE COLOR received FDA 510(k) clearance on 2011-04-05, under 510(k) number K110178.

Who is the listed applicant for ESTELITE COLOR?

The FDA 510(k) record lists Tokuyama Dental Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESTELITE COLOR?

The FDA product code for ESTELITE COLOR is EBF.

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 Tokuyama Dental Corporation 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.

K203760Tokuyama Universal Bond IIK203598Omnichroma Flow BulkK193537Omnichroma FlowK190940Tokuyama Rebase IIIK180613Estelite Universal FlowK173275OMNICHROMA

View all 18 devices →

Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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.

↑