Cleared Traditional

K220648 - OMF ASP System (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220648 · Vha Dean · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
157d
Days
Class 2
Risk

K220648 is an FDA 510(k) clearance for the OMF ASP System. Classified as Driver, Wire, And Bone Drill, Manual (product code DZJ), Class II - Special Controls.

Submitted by Vha Dean (Washington, US). The FDA issued a Cleared decision on August 11, 2022 after a review of 157 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Vha Dean devices

Submission Details

510(k) Number K220648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 127d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZJ Driver, Wire, And Bone Drill, Manual
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Lg Strategies, LLC
Laura Gilmour

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DZJ Driver, Wire, And Bone Drill, Manual

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