Cleared Traditional

K926033 - VINYL POLYSILOXANE IMPRESSION SYSTEM AND RE'CORD

K926033 is an FDA 510(k) clearance for VINYL POLYSILOXANE IMPRESSION SYSTEM AN..., manufactured by Harry J. Bosworth Co.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K926033

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
Combination Product No
PCCP Authorized No
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.

ELW Device Classification - Class 2, Special Controls

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 288
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K926033.
VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM
K930248 · Crown Delta Corp. · Jan 1994
EXA BITE REGISTRATION MATERIAL
K933206 · GC America, Inc. · Sep 1993
FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL
K932459 · 3M Company · Aug 1993
TRIANGULAR JAW MICROLARYNGEAL FORCEPS
K925370 · Pilling Co. · Mar 1993
Q3 (LIGHT AND UNIVERSAL) IMPRESSION MATERIAL
K923202 · Jeneric/Pentron, Inc. · Aug 1992
CORRECTED-V.P.S.
K914178 · Jeneric/Pentron, Inc. · Apr 1992