Cleared Traditional

K223892 - DentMix VPS Impression Material

K223892 is an FDA 510(k) clearance for DentMix VPS Impression Material, manufactured by Innovative Product Brands, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K223892 · Innovative Product Brands, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
120d
Days
Class 2
Risk

K223892 is an FDA 510(k) clearance for the DentMix VPS Impression Material. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Innovative Product Brands, Inc. (Highland, US). The FDA issued a Cleared decision on April 27, 2023 after a review of 120 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 Innovative Product Brands, Inc. devices

FDA 510(k) Submission Details - K223892

510(k) Number K223892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2022
Decision Date April 27, 2023
Days to Decision 120 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
7d faster than avg
Panel avg: 127d · This submission: 120d
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 199
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K223892.
Elastic Impression Material
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Speedex Light Body
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K233954 · B&E Korea Co., Ltd. · Feb 2024
No Stress Impress
K213175 · No Stress Impress, LLC · Jan 2023
Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty
K214086 · Genoss Co., Ltd. · Dec 2022
DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)
K222741 · Hdi, Inc. · Nov 2022