Cleared Traditional

K926033 - VINYL POLYSILOXANE IMPRESSION SYSTEM AN...

K926033 is the FDA 510(k) clearance for VINYL POLYSILOXANE IMPRESSION SYSTEM AN... by Harry J. Bosworth Co.. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K926033 · Harry J. Bosworth Co. · Dental device
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May 1993
Decision
155d
Days
Class 2
Risk

K926033 is an FDA 510(k) clearance for the VINYL POLYSILOXANE IMPRESSION SYSTEM AND RE'CORD. 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 May 5, 1993 after a review of 155 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Harry J. Bosworth Co. devices

Submission Details

510(k) Number K926033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1992
Decision Date May 05, 1993
Days to Decision 155 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
28d slower than avg
Panel avg: 127d · This submission: 155d
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 K926033.
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
Q3 (LIGHT AND UNIVERSAL) IMPRESSION MATERIAL
K923202 · Jeneric/Pentron, Inc. · Aug 1992
CORRECTED-V.P.S.
K914178 · Jeneric/Pentron, Inc. · Apr 1992
CORRECT-S.I.M.
K914437 · Jeneric/Pentron, Inc. · Jan 1992