Cleared Traditional

OMF ASP System

K220648 · Vha Dean · Dental
Aug 2022
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K220648 is an FDA 510(k) clearance for the OMF ASP System, a Driver, Wire, And Bone Drill, Manual (Class II — Special Controls, product code DZJ), submitted by Vha Dean (Washington, US). The FDA issued a Cleared decision on August 11, 2022, 157 days after receiving the submission on March 7, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K220648 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2022
Decision Date August 11, 2022
Days to Decision 157 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