Cleared Traditional

EmbedMed

K220366 · 3D Lifeprints UK , Ltd. · Dental
Sep 2022
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K220366 is an FDA 510(k) clearance for the EmbedMed, a Driver, Wire, And Bone Drill, Manual (Class II — Special Controls, product code DZJ), submitted by 3D Lifeprints UK , Ltd. (West Derby, Liverpool, Merseyside, GB). The FDA issued a Cleared decision on September 30, 2022, 234 days after receiving the submission on February 8, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K220366 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2022
Decision Date September 30, 2022
Days to Decision 234 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZJ — Driver, Wire, And Bone Drill, Manual
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120