Cleared Abbreviated

K003090 - MIDMARK PROCENTER INSTRUMENT DELIVERY S...

K003090 is the FDA 510(k) clearance for MIDMARK PROCENTER INSTRUMENT DELIVERY S... by Midmark Corp.. It is a Class 1 Dental device (product code EIA) cleared through the Abbreviated 510(k) pathway after a 15-day FDA review.

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
Combination Product No
PCCP Authorized No
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.

Regulatory Consultant

Intertek Testing Services
DONALD J SHERRATT

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 - EIA Unit, Operative Dental

All 61
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