Cleared Traditional

K080266 - WELL-PEX

K080266 is an FDA 510(k) clearance for WELL-PEX, manufactured by Vericom Co., Ltd.. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 5-day FDA review.

K080266 · Vericom Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
5d
Days
Class 2
Risk

K080266 is an FDA 510(k) clearance for the WELL-PEX. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Vericom Co., Ltd. (Anyang-Si, Gyeonggi-Do, KR). The FDA issued a Cleared decision on February 6, 2008 after a review of 5 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vericom Co., Ltd. devices

FDA 510(k) Submission Details - K080266

510(k) Number K080266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2008
Decision Date February 06, 2008
Days to Decision 5 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 127d · This submission: 5d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KIF Device Classification - Class 2, Special Controls

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
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 - KIF Resin, Root Canal Filling

All 84
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K080266.
BIO-C SEALER
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K071106 · Ultradent Products, Inc. · May 2007
CZ-S2000
K060946 · Parkell, Inc. · Jun 2006
ENDOREZ
K042756 · Ultradent Products, Inc. · Oct 2004