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 a medical device manufactured by Kids-E-Dental Llp. It received FDA 510(k) clearance on 2024-03-06 under approval 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. It is manufactured by Kids-E-Dental Llp. The 510(k) number is K240619.

When was e-SDF approved by the FDA?

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

What company makes e-SDF?

e-SDF is manufactured by Kids-E-Dental Llp.

What is the FDA product code for e-SDF?

The FDA product code for e-SDF is PHR.

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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.