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FDA 510(k)

CARIES STAIN

K-Number: K973200 · 1997-11-06

ApplicantParkell, Inc.
Decision Date1997-11-06
Product CodeLFC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CARIES STAIN is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 1997-11-06 under 510(k) number K973200. 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 STAIN?

CARIES STAIN is a medical device that received FDA 510(k) clearance on 1997-11-06. The listed applicant is Parkell, Inc.. The 510(k) number is K973200.

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

CARIES STAIN received FDA 510(k) clearance on 1997-11-06, under 510(k) number K973200.

Who is the listed applicant for CARIES STAIN?

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

What is the FDA product code for CARIES STAIN?

The FDA product code for CARIES STAIN is LFC.

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Other records listing Parkell, 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.

K243254Parkell Pit and Fissure SealantK210259Parkell Self-Adhesive CementK191103Parkell Desensitizer GelK190930SmarTemp X1K182296HyperFil-LVK172176Parkell Universal Adhesive

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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/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.

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