Cleared Traditional

K930248 - VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM

K930248 is an FDA 510(k) clearance for VINYL POLYSILOXANE 2 COMPONENT VULCANIZ..., manufactured by Crown Delta Corp.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 353-day FDA review.

K930248 · Crown Delta Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
353d
Days
Class 2
Risk

K930248 is an FDA 510(k) clearance for the VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Crown Delta Corp. (Yorktown Heights, US). The FDA issued a Cleared decision on January 7, 1994 after a review of 353 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Crown Delta Corp. devices

FDA 510(k) Submission Details - K930248

510(k) Number K930248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1993
Decision Date January 07, 1994
Days to Decision 353 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
226d slower than avg
Panel avg: 127d · This submission: 353d
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 265
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K930248.
EXTRUDE
K940379 · Sybron Dental Specialties, Inc. · Mar 1994
ALPHA-DENT
K940120 · Wallace A. Erickson & Co. · Feb 1994
TREND SET 2 PLUS
K936070 · Confi-Dental Products Co. · Feb 1994
EXA BITE REGISTRATION MATERIAL
K933206 · GC America, Inc. · Sep 1993
FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL
K932459 · 3M Company · Aug 1993
VINYL POLYSILOXANE IMPRESSION SYSTEM AND RE'CORD
K926033 · Harry J. Bosworth Co. · May 1993