Cleared Traditional

MONOSTERYL

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

About This 510(k) Submission

K926205 is an FDA 510(k) clearance for the MONOSTERYL, a Bur, Dental (Class I — General Controls, product code EJL), submitted by Utensili Super Abrasivi ((Milan), Italy, IT). The FDA issued a Cleared decision on February 10, 1994, 428 days after receiving the submission on December 9, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.3240.

Submission Details

510(k) Number K926205 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EJL — Bur, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.3240