Cleared Traditional

VONFLEX S BITE

K140966 · Vericom Co., Ltd. · Dental
Aug 2014
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K140966 is an FDA 510(k) clearance for the VONFLEX S BITE, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Vericom Co., Ltd. (Chuncheon-Si, Gangwon - Do, KR). The FDA issued a Cleared decision on August 15, 2014, 122 days after receiving the submission on April 15, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K140966 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2014
Decision Date August 15, 2014
Days to Decision 122 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

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