Cleared Traditional

SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL

K052409 · Sultan Chemists, Inc. · Dental
Oct 2005
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K052409 is an FDA 510(k) clearance for the SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Sultan Chemists, Inc. (Englewood, US). The FDA issued a Cleared decision on October 20, 2005, 49 days after receiving the submission on September 1, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K052409 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2005
Decision Date October 20, 2005
Days to Decision 49 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code ELW — Material, Impression
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3660

Similar Devices — ELW Material, Impression

All 400
Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);
K253501 · Vigodent Ind?stria E Comercio Ltda · Oct 2025
JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST
K250969 · Dent4you AG · Jun 2025
Elastic Impression Material
K241924 · Beijing Okvd Biological Technology , Ltd. · Dec 2024
Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator
K242360 · Dent4you AG · Nov 2024
Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu
K233954 · B&E Korea Co., Ltd. · Feb 2024
DentMix VPS Impression Material
K223892 · Innovative Product Brands, Inc. · Apr 2023