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FDA 510(k)

Diafil & Diafil Capsule

K-Number: K210421 · 2021-06-28

Decision Date2021-06-28
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Diafil & Diafil Capsule is a medical device manufactured by DiaDent Group International. It received FDA 510(k) clearance on 2021-06-28 under approval number K210421. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diafil & Diafil Capsule?

Diafil & Diafil Capsule is a medical device that received FDA 510(k) clearance on 2021-06-28. It is manufactured by DiaDent Group International. The 510(k) number is K210421.

When was Diafil & Diafil Capsule approved by the FDA?

Diafil & Diafil Capsule received FDA 510(k) clearance on 2021-06-28, under approval number K210421.

What company makes Diafil & Diafil Capsule?

Diafil & Diafil Capsule is manufactured by DiaDent Group International.

What is the FDA product code for Diafil & Diafil Capsule?

The FDA product code for Diafil & Diafil Capsule is EBF.

Other Devices by DiaDent Group International

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Related Devices (Code: EBF)

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.