Cleared Traditional

VONFLEX S BITE (K140966) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K140966 · Vericom Co., Ltd. · Dental device
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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

Submission Details

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.

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 Peers - ELW Material, Impression

All 85
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