Cleared Traditional

CHALLENGE-EVER (K102223) - FDA 510(k) Clearance

Class I Dental device.

K102223 · Hallim Dentech Co., Ltd. · Dental device
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Feb 2011
Decision
203d
Days
Class 1
Risk

K102223 is an FDA 510(k) clearance for the CHALLENGE-EVER. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Hallim Dentech Co., Ltd. (Fullerton, US). The FDA issued a Cleared decision on February 25, 2011 after a review of 203 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Hallim Dentech Co., Ltd. devices

Submission Details

510(k) Number K102223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2010
Decision Date February 25, 2011
Days to Decision 203 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 127d · This submission: 203d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

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