FDA 510(k)

G-CAM

K-Number: K220329 · 2022-08-16

Decision Date2022-08-16

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

G-CAM is the device name listed in this FDA 510(k) record. The listed applicant is Graphenano Dental S.L.. It received FDA 510(k) clearance on 2022-08-16 under 510(k) number K220329. 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 G-CAM?

G-CAM is a medical device that received FDA 510(k) clearance on 2022-08-16. The listed applicant is Graphenano Dental S.L.. The 510(k) number is K220329.

When did G-CAM receive FDA 510(k) clearance?

G-CAM received FDA 510(k) clearance on 2022-08-16, under 510(k) number K220329.

Who is the listed applicant for G-CAM?

The FDA 510(k) record lists Graphenano Dental S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for G-CAM?

The FDA product code for G-CAM is EBF.

Other records listing Graphenano Dental S.L. 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.

K253236G-BLOCK

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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.