Cleared Traditional

K926205 - MONOSTERYL

K926205 is an FDA 510(k) clearance for MONOSTERYL, manufactured by Utensili Super Abrasivi. The device is a Class 1 Dental device with product code EJL cleared through the Traditional 510(k) pathway after a 428-day FDA review.

K926205 · Utensili Super Abrasivi · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K926205

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.

EJL Device Classification - Class 1, General Controls

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.

Regulatory Peers - EJL Bur, Dental

All 8
Devices cleared under the same product code (EJL) and FDA review panel - the closest regulatory comparables to K926205.
SMARTBURS
K080687 · S.S. White Burs, Inc. · Jun 2008
CERADRILL
K071352 · Gebr. Brasseler GmbH & Co. KG · Jun 2007
BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS
K061383 · B.T.I. Biotechnology Institute, Sl. · Aug 2006
DIAMONDS BURS-COMPOSIT FINISHING
K854690 · Almore Intl., Inc. · Mar 1986
DIAMOND BURS-HANDPIECE
K854691 · Almore Intl., Inc. · Mar 1986
DENTAL INSTRUMENTS
K823314 · Miltex, Inc. · Nov 1982