Cleared Traditional

No Stress Impress (K213175) - FDA 510(k) Clearance

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

K213175 · No Stress Impress, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2023
Decision
478d
Days
Class 2
Risk

K213175 is an FDA 510(k) clearance for the No Stress Impress. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by No Stress Impress, LLC (Wilmington, US). The FDA issued a Cleared decision on January 19, 2023 after a review of 478 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all No Stress Impress, LLC devices

Submission Details

510(k) Number K213175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2021
Decision Date January 19, 2023
Days to Decision 478 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
351d slower than avg
Panel avg: 127d · This submission: 478d
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 Consultant

Wagoner Consulting Llg
Cheryl Wagoner

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ELW Material, Impression

All 92
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K213175.
Speedex Light Body
K242360 · Dent4you AG · Nov 2024
Chemi-SiL (HB, MB, LB, LBS)
K233954 · B&E Korea Co., Ltd. · Feb 2024
DentMix VPS Impression Material
K223892 · Innovative Product Brands, Inc. · Apr 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
Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)
K213244 · Prevest Denpro Limited · Sep 2022