Cleared Traditional

YOUNG D'GRANULATOR

K932255 · Young Dental Manufacturing Co. 1, LLC · Dental
Apr 1994
Decision
340d
Days
Class 2
Risk

About This 510(k) Submission

K932255 is an FDA 510(k) clearance for the YOUNG D'GRANULATOR, a Handpiece, Rotary Bone Cutting (Class II — Special Controls, product code KMW), submitted by Young Dental Manufacturing Co. 1, LLC (Earth City, US). The FDA issued a Cleared decision on April 15, 1994, 340 days after receiving the submission on May 10, 1993. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K932255 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 1993
Decision Date April 15, 1994
Days to Decision 340 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code KMW — Handpiece, Rotary Bone Cutting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120