Cleared Traditional

K152615 - Vonflex S

K152615 is an FDA 510(k) clearance for Vonflex S, 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 416-day FDA review.

K152615 · Vericom Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
416d
Days
Class 2
Risk

K152615 is an FDA 510(k) clearance for the Vonflex S. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Vericom Co., Ltd. (Chuncheon-Si, KR). The FDA issued a Cleared decision on November 3, 2016 after a review of 416 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Vericom Co., Ltd. devices

FDA 510(k) Submission Details - K152615

510(k) Number K152615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2015
Decision Date November 03, 2016
Days to Decision 416 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
288d slower than avg
Panel avg: 128d · This submission: 416d
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 341
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K152615.
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