Cleared Traditional

K940402 - SUPERGEL/SUPPRESSED DUST

K940402 is the FDA 510(k) clearance for SUPERGEL/SUPPRESSED DUST by Harry J. Bosworth Co.. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K940402 · Harry J. Bosworth Co. · Dental device
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Mar 1994
Decision
60d
Days
Class 2
Risk

K940402 is an FDA 510(k) clearance for the SUPERGEL/SUPPRESSED DUST. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Harry J. Bosworth Co. (Skokie, US). The FDA issued a Cleared decision on March 28, 1994 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Harry J. Bosworth Co. devices

Submission Details

510(k) Number K940402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1994
Decision Date March 28, 1994
Days to Decision 60 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
67d faster than avg
Panel avg: 127d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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.

Regulatory Peers - ELW Material, Impression

All 116
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K940402.
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PRETREATMENT SOLUTION
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HYDROCOLLOID HEATING UNIT
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EXTRUDE
K940379 · Sybron Dental Specialties, Inc. · Mar 1994
EXA BITE REGISTRATION MATERIAL
K933206 · GC America, Inc. · Sep 1993
FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL
K932459 · 3M Company · Aug 1993