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)

CARIES DETECTOR

K-Number: K012733 · 2001-09-14

ApplicantKuraray Medical, Inc.
Decision Date2001-09-14
Product CodeLFC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CARIES DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Medical, Inc.. It received FDA 510(k) clearance on 2001-09-14 under 510(k) number K012733. The device is classified under product code LFC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARIES DETECTOR?

CARIES DETECTOR is a medical device that received FDA 510(k) clearance on 2001-09-14. The listed applicant is Kuraray Medical, Inc.. The 510(k) number is K012733.

When did CARIES DETECTOR receive FDA 510(k) clearance?

CARIES DETECTOR received FDA 510(k) clearance on 2001-09-14, under 510(k) number K012733.

Who is the listed applicant for CARIES DETECTOR?

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

What is the FDA product code for CARIES DETECTOR?

The FDA product code for CARIES DETECTOR is LFC.

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 Kuraray Medical, 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.

K120378PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA SK120379PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA SK111975CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACKK100328CLEARFIL MAJETY POSTERIORK092281CLEARFIL MAJESTY POSTERIOR PLTK081583CLEARFIL SA CEMENT

View all 42 devices →

Related Devices (Code: LFC)

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.

K222560BlueCheck™ Caries Detection & MonitoringIncisive Technologies Pty, Ltd.K200601LumiCare Caries Diagnostic RinseGreenMark Biomedical, Inc.K193447Vista DyesInter-Med/Vista Dental ProductsK102821DISCOVREDPhoenix Dental, Inc.K060330SEE-IT CARIES DETECTORRonvig Dental Mfg. A/SK030807CARIES INDICATORConfi-Dental Products Co.

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.

↑