Cleared Traditional

K943574 - CAPTURE IMPRESSION MATERIAL

K943574 is an FDA 510(k) clearance for CAPTURE IMPRESSION MATERIAL, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K943574 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
32d
Days
Class 2
Risk

K943574 is an FDA 510(k) clearance for the CAPTURE IMPRESSION MATERIAL. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on August 23, 1994 after a review of 32 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 Dentsply Intl. devices

FDA 510(k) Submission Details - K943574

510(k) Number K943574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1994
Decision Date August 23, 1994
Days to Decision 32 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 127d · This submission: 32d
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 322
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K943574.
PERMADYNE PENTA (HIGH & LOW VISCOSITY)
K953027 · Espe GmbH & Co. Kg. · Jul 1995
S & C VINYL POLYSILOXANE IMPRESSION MATERIAL
K951075 · S & C Polymer GmbH · Mar 1995
GC SURFLEX F
K943388 · GC America, Inc. · Sep 1994
ULTRA HYDROPHILIC ALGINAE
K943475 · Essential Dental Systems, Inc. · Aug 1994
ORTHALGENAT IMPRESSION MATERIAL
K942666 · Dentauraum, Inc. · Aug 1994
CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS
K940860 · Ultradent Products, Inc. · May 1994