FDA 510(k)

e-SDF

K-Number: K240619 · 2024-03-06

Decision Date2024-03-06

Product CodePHR

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

e-SDF is the device name listed in this FDA 510(k) record. The listed applicant is Kids-E-Dental Llp. It received FDA 510(k) clearance on 2024-03-06 under 510(k) number K240619. The device is classified under product code PHR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the e-SDF?

e-SDF is a medical device that received FDA 510(k) clearance on 2024-03-06. The listed applicant is Kids-E-Dental Llp. The 510(k) number is K240619.

When did e-SDF receive FDA 510(k) clearance?

e-SDF received FDA 510(k) clearance on 2024-03-06, under 510(k) number K240619.

Who is the listed applicant for e-SDF?

The FDA 510(k) record lists Kids-E-Dental Llp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for e-SDF?

The FDA product code for e-SDF is PHR.

Related Devices (Code: PHR)

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.

K250222SDF ProBelport Company, Inc., Gingi-Pak K241041Silver Fluoride Hypersensitivity VarnishYoung Dental Manufacturing Co. 1, LLC K240059FAgamin®Tedequim Srl K222459Centrix FluoroSilver Silver Diamine Fluoride 38%Centrix, Inc.K222323Black DiamondElevate Oral Care, LLC K172047Riva StarSdi Limited

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.