Cleared Traditional

K102223 - CHALLENGE-EVER

K102223 is an FDA 510(k) clearance for CHALLENGE-EVER, manufactured by Hallim Dentech Co., Ltd.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K102223 · Hallim Dentech Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K102223

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.

EIA Device Classification - Class 1, General Controls

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.

Regulatory Peers - EIA Unit, Operative Dental

All 110
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K102223.
S200, S300
K133412 · Cefla S.C. · Jan 2015
CS 1200
K112321 · Carestream Health, Inc. · Nov 2011
AMC-20 PORTABLE DENTAL CART MODEL AMC-20
K101332 · Aseptico, Inc. · Apr 2011
A-DEC 200 DENTAL SYSTEM
K102234 · A-Dec, Inc. · Nov 2010
STERN'S S250 NORDAM
K092917 · Cefla S.C. · Jun 2010
KODAK 1500 INTRAORAL CAMERA
K091186 · Carestream Health, Inc. · Aug 2009