Cleared Traditional

K103121 - ECO-S

K103121 is an FDA 510(k) clearance for ECO-S, manufactured by Vericom Co., Ltd.. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 4-day FDA review.

K103121 · Vericom Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
4d
Days
Class 2
Risk

K103121 is an FDA 510(k) clearance for the ECO-S. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Vericom Co., Ltd. (Anyang-Si, Gyeonggi-Do, KR). The FDA issued a Cleared decision on October 26, 2010 after a review of 4 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - 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 - K103121

510(k) Number K103121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2010
Decision Date October 26, 2010
Days to Decision 4 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
124d faster than avg
Panel avg: 128d · This submission: 4d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

EBC Device Classification - Class 2, Special Controls

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
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.
MARC M MOUSER

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 - EBC Sealant, Pit And Fissure, And Conditioner

All 110
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K103121.
BEAUTISEALANT
K111782 · Shofu Dental Corporation · Sep 2011
BPA-FREE PIT AND FISSURE SEALANT
K110058 · Novocol Inc. Dba Septodont and Confi-Dental Produc · Mar 2011
DMP PIT & FISSURE SEALANT
K102252 · Dmp, Ltd. · Dec 2010
ULTRASEAL ID
K101245 · Ultradent Products, Inc. · Sep 2010
INFILTRATION KIT
K100062 · Dmg USA, Inc. · Mar 2010
SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT
K093059 · Classone Orthodontics, Inc. · Feb 2010