Cleared Traditional

K052090 - SPLASH! IMPRESSION MATERIAL DEVICE

K052090 is an FDA 510(k) clearance for SPLASH! IMPRESSION MATERIAL DEVICE, manufactured by Discus Dental, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 3-day FDA review.

K052090 · Discus Dental, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
3d
Days
Class 2
Risk

K052090 is an FDA 510(k) clearance for the SPLASH! IMPRESSION MATERIAL DEVICE. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Discus Dental, Inc. (Culver City, US). The FDA issued a Cleared decision on August 5, 2005 after a review of 3 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.

FDA 510(k) Submission Details - K052090

510(k) Number K052090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2005
Decision Date August 05, 2005
Days to Decision 3 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
125d faster than avg
Panel avg: 128d · This submission: 3d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

California Department of Health Services
ALFREDO J QUATTRONE

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 377
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K052090.
POLY SILOXANE IMPRESSION MATERIAL
K053014 · Clinician'S Choice Dental Products, Inc. · Nov 2005
POLY SILOXANE IMPRESSION MATERIAL
K053018 · Millennium Dental International, Inc. · Nov 2005
SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL
K052409 · Sultan Chemists, Inc. · Oct 2005
FUTURE WASH/YPS
K051797 · 3M Espe AG Dental Products · Jul 2005
ELITE IMPLANT
K050417 · Zhermack S.P.A. · Jul 2005
HYDROGUM 5
K051424 · Zhermack S.P.A. · Jul 2005
K052090 · SPLASH! IMPRESSION MATERIAL DEVICE
Download PDF FDA Summary Discus Dental, Inc.