Cleared Traditional

DentMix VPS Impression Material (K223892) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223892 · Innovative Product Brands, Inc. · Dental device
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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

Submission Details

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.

Device Classification

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 84
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K223892.
Elastic Impression Material
K241924 · Beijing Okvd Biological Technology , Ltd. · Dec 2024
Speedex Light Body
K242360 · Dent4you AG · Nov 2024
Chemi-SiL (HB, MB, LB, LBS)
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