Cleared Traditional

K201184 - Lascod Impression Materials

K201184 is the FDA 510(k) clearance for Lascod Impression Materials by Lascod Spa. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 4-day FDA review.

K201184 · Lascod Spa · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
4d
Days
Class 2
Risk

K201184 is an FDA 510(k) clearance for the Lascod Impression Materials. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Lascod Spa (Sesto Fiorentino, IT). The FDA issued a Cleared decision on May 5, 2020 after a review of 4 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 Lascod Spa devices

Submission Details

510(k) Number K201184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2020
Decision Date May 05, 2020
Days to Decision 4 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 127d · This submission: 4d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Third Party Review Group, LLC
Dave Yungvirt

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 140
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K201184.
HySil Plus Impression Materials
K210041 · Osstem Implant Co., Ltd. · Mar 2021
Impression Material
K201483 · Zhengzhou Huaer Electro Optics Technology Co., Ltd. · Oct 2020
A-Silicone for Bite Registration
K201684 · Shandong Huge Dental Material Corporation · Sep 2020
HySil Super Fast Impression Materials
K192941 · Osstem Implant Co., Ltd. · Jan 2020
StoneBite and StoneBite scan
K190571 · Dreve Dentamid GmbH · Nov 2019
VPS Impression Material
K191034 · Hygedent, Inc. · Sep 2019