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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 128d · 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 Consultant

Underwriters Laboratories, Inc.
MORTEN SIMON CHRISTENSEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KIF Resin, Root Canal Filling

All 138
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K080266.
IROOT BP, MODEL IRBP 4609
K082943 · Innovative Bioceramix, Inc. · Jan 2009
IROOT SP
K080917 · Innovative Bioceramix, Inc. · Apr 2008
MTA ROOT CANAL SEALER
K080203 · Dentsply Interntional · Mar 2008
MTA ADVANCED MATERIAL
K073218 · Dentsply Interntional · Jan 2008
ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399
K071106 · Ultradent Products, Inc. · May 2007
EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM
K063856 · Essential Dental Systems, Inc. · Feb 2007