Cleared Traditional

K140966 - VONFLEX S BITE

K140966 is an FDA 510(k) clearance for VONFLEX S BITE, manufactured by Vericom Co., Ltd.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K140966 · Vericom Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
122d
Days
Class 2
Risk

K140966 is an FDA 510(k) clearance for the VONFLEX S BITE. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Vericom Co., Ltd. (Chuncheon-Si, Gangwon - Do, KR). The FDA issued a Cleared decision on August 15, 2014 after a review of 122 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Vericom Co., Ltd. devices

FDA 510(k) Submission Details - K140966

510(k) Number K140966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 127d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - ELW Material, Impression

All 196
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K140966.
Hyflex Heavy, Hyflex Mono, Hyflex Light
K151262 · Osstem Implant Co., Ltd. · Sep 2015
Accu-Dent XD Tray, Accu-Dent XD Syringe
K143575 · Ivoclar Vivadent, Inc. · Apr 2015
MARK3
K141092 · Cavex Holland BV · Dec 2014
GC BLUE SILICONE
K120521 · GC America, Inc. · May 2012
AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL
K113406 · Dentsply International, Inc. · Feb 2012
FIT CHECKER ADVANCED
K110871 · GC America, Inc. · Jun 2011