EmbedMed

FDA 510(k) K220366 · 3D Lifeprints UK , Ltd.

Substantially Equivalent

510(k) numberK220366

Submission

Device name
EmbedMed
Applicant
3D Lifeprints UK , Ltd.
West Derby, Liverpool, Merseyside, GB
Received
February 8, 2022
Decision date
September 30, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DZJ – Driver, Wire, And Bone Drill, Manual
Device class
Class II (moderate risk)
Regulation
21 CFR 872.4120
Specialty
Dental

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Questions and answers

When was EmbedMed cleared by the FDA?

EmbedMed (K220366) received a 510(k) decision of Substantially Equivalent on September 30, 2022, 234 days after the submission was received.

What is the product code of K220366?

The FDA product code is DZJ – Driver, Wire, And Bone Drill, Manual, a Class II (moderate risk) device regulated under 21 CFR 872.4120.