Cleared Traditional

K151535 - Cavex Cream Alginate

K151535 is an FDA 510(k) clearance for Cavex Cream Alginate, manufactured by Cavex Holland BV. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K151535 · Cavex Holland BV · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
142d
Days
Class 2
Risk

K151535 is an FDA 510(k) clearance for the Cavex Cream Alginate. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Cavex Holland BV (Haarlem, NL). The FDA issued a Cleared decision on October 28, 2015 after a review of 142 days - within the typical 510(k) review window.

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 Cavex Holland BV devices

FDA 510(k) Submission Details - K151535

510(k) Number K151535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2015
Decision Date October 28, 2015
Days to Decision 142 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
15d slower than avg
Panel avg: 127d · This submission: 142d
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 195
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K151535.
HySil Impression Materials
K170736 · Osstem Implant Co., Ltd. · Jun 2017
Identic and KromaFaze Alginate Dental Impression Materials
K160441 · Kerr Corporation · Jun 2016
NoCord
K152826 · Centrix, Inc. · May 2016
Hyflex Heavy, Hyflex Mono, Hyflex Light
K151262 · Osstem Implant Co., Ltd. · Sep 2015
Accu-Dent XD Tray, Accu-Dent XD Syringe
K143575 · Ivoclar Vivadent, Inc. · Apr 2015
MARK3
K141092 · Cavex Holland BV · Dec 2014