Cleared Traditional

K932255 - YOUNG D'GRANULATOR

K932255 is an FDA 510(k) clearance for YOUNG D'GRANULATOR, manufactured by Young Dental Manufacturing Co. 1, LLC. The device is a Class 2 Dental device with product code KMW cleared through the Traditional 510(k) pathway after a 340-day FDA review.

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

K932255 is an FDA 510(k) clearance for the YOUNG D'GRANULATOR. Classified as Handpiece, Rotary Bone Cutting (product code KMW), Class II - Special Controls.

Submitted by Young Dental Manufacturing Co. 1, LLC (Earth City, US). The FDA issued a Cleared decision on April 15, 1994 after a review of 340 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Young Dental Manufacturing Co. 1, LLC devices

FDA 510(k) Submission Details - K932255

510(k) Number K932255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 127d · This submission: 340d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KMW Device Classification - Class 2, Special Controls

Product Code KMW Handpiece, Rotary Bone Cutting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
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.