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FDA 510(k)

CARIES INDICATOR

K-Number: K030807 · 2003-06-09

ApplicantConfi-Dental Products Co.
Decision Date2003-06-09
Product CodeLFC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CARIES INDICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Confi-Dental Products Co.. It received FDA 510(k) clearance on 2003-06-09 under 510(k) number K030807. 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 INDICATOR?

CARIES INDICATOR is a medical device that received FDA 510(k) clearance on 2003-06-09. The listed applicant is Confi-Dental Products Co.. The 510(k) number is K030807.

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

CARIES INDICATOR received FDA 510(k) clearance on 2003-06-09, under 510(k) number K030807.

Who is the listed applicant for CARIES INDICATOR?

The FDA 510(k) record lists Confi-Dental Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARIES INDICATOR?

The FDA product code for CARIES INDICATOR is LFC.

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Other records listing Confi-Dental Products Co. 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.

K030743ETCHANT 40%K955328CONFI-BONDK955329RESILIENCE M5 PROTECTION PLUSK954988CRYSTALLESSENCEK952930DENTRAY II PLUS TRAY ADHESIVEK946307CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE

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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/SK012733CARIES DETECTORKuraray Medical, 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.

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