FDA 510(k)

FAgamin®

K-Number: K240059 · 2024-05-16

Decision Date2024-05-16

Product CodePHR

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

FAgamin® is the device name listed in this FDA 510(k) record. The listed applicant is Tedequim Srl. It received FDA 510(k) clearance on 2024-05-16 under 510(k) number K240059. 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 FAgamin®?

FAgamin® is a medical device that received FDA 510(k) clearance on 2024-05-16. The listed applicant is Tedequim Srl. The 510(k) number is K240059.

When did FAgamin® receive FDA 510(k) clearance?

FAgamin® received FDA 510(k) clearance on 2024-05-16, under 510(k) number K240059.

Who is the listed applicant for FAgamin®?

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

What is the FDA product code for FAgamin®?

The FDA product code for FAgamin® 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 K240619e-SDFKids-E-Dental Llp K222459Centrix FluoroSilver Silver Diamine Fluoride 38%Centrix, Inc.K222323Black DiamondElevate Oral Care, LLC K172047Riva StarSdi Limited

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.