Cleared Abbreviated

K003090 - MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM (FDA 510(k) Clearance)

Class I Dental device.

K003090 · Midmark Corp. · Dental device
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Oct 2000
Decision
15d
Days
Class 1
Risk

K003090 is an FDA 510(k) clearance for the MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on October 18, 2000 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Midmark Corp. devices

Submission Details

510(k) Number K003090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2000
Decision Date October 18, 2000
Days to Decision 15 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 127d · This submission: 15d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

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