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FDA 510(k)

KAR-D-TEK

K-Number: K913405 · 1991-10-28

ApplicantGresco Products, Inc.
Decision Date1991-10-28
Product CodeLFC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KAR-D-TEK is the device name listed in this FDA 510(k) record. The listed applicant is Gresco Products, Inc.. It received FDA 510(k) clearance on 1991-10-28 under 510(k) number K913405. 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 KAR-D-TEK?

KAR-D-TEK is a medical device that received FDA 510(k) clearance on 1991-10-28. The listed applicant is Gresco Products, Inc.. The 510(k) number is K913405.

When did KAR-D-TEK receive FDA 510(k) clearance?

KAR-D-TEK received FDA 510(k) clearance on 1991-10-28, under 510(k) number K913405.

Who is the listed applicant for KAR-D-TEK?

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

What is the FDA product code for KAR-D-TEK?

The FDA product code for KAR-D-TEK is LFC.

Other records listing Gresco Products, 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.

K981524PRILANEK910813MET-ETCHK910803ENAMEL ETCHING GELK901973CP-3 DENTAL POLISHING MATERIALK854495GRESCO N.P. DENTAL ALLOYK854494CERAM-ETCH

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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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