Cleared Traditional

K926376 - MION 525

K926376 is an FDA 510(k) clearance for MION 525, manufactured by Mion International Corp.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 668-day FDA review.

K926376 · Mion International Corp. · Dental device
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Oct 1994
Decision
668d
Days
Class 2
Risk

K926376 is an FDA 510(k) clearance for the MION 525. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Mion International Corp. (Winslow, US). The FDA issued a Cleared decision on October 21, 1994 after a review of 668 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Mion International Corp. devices

FDA 510(k) Submission Details - K926376

510(k) Number K926376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1992
Decision Date October 21, 1994
Days to Decision 668 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
541d slower than avg
Panel avg: 127d · This submission: 668d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 Peers - EMA Cement, Dental

All 437
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K926376.
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