Cleared Abbreviated

G-CAM

K220329 · Graphenano Dental S.L. · Dental
Aug 2022
Decision
193d
Days
Class 2
Risk

About This 510(k) Submission

K220329 is an FDA 510(k) clearance for the G-CAM, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Graphenano Dental S.L. (Yecla, ES). The FDA issued a Cleared decision on August 16, 2022, 193 days after receiving the submission on February 4, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K220329 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 2022
Decision Date August 16, 2022
Days to Decision 193 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690