Cleared Traditional

MONOSTERYL (K926205) - FDA 510(k) Clearance

Class I Dental device.

K926205 · Utensili Super Abrasivi · Dental device
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Feb 1994
Decision
428d
Days
Class 1
Risk

K926205 is an FDA 510(k) clearance for the MONOSTERYL. Classified as Bur, Dental (product code EJL), Class I - General Controls.

Submitted by Utensili Super Abrasivi ((Milan), Italy, IT). The FDA issued a Cleared decision on February 10, 1994 after a review of 428 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3240 - 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 Utensili Super Abrasivi devices

Submission Details

510(k) Number K926205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1992
Decision Date February 10, 1994
Days to Decision 428 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
301d slower than avg
Panel avg: 127d · This submission: 428d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EJL Bur, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3240
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.