510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K102223Substantially Equivalent

Challenge-Ever

Hallim Dentech Co., Ltd., Fullerton CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K102223 is the FDA 510(k) clearance record for CHALLENGE-EVER, a class I device, cleared for Hallim Dentech Co., Ltd. on under FDA product code EIA (Unit, Operative Dental). FDA records list one 510(k) clearance for Hallim Dentech Co., Ltd. As of , FDA records show no recalls naming K102223.

Clearance record

Decision date
Received
(203 days to decision)
Product code
EIA Unit, Operative Dental
Regulation
21 CFR 872.6640
Device class
Class I
Review panel
Dental
Applicant
Hallim Dentech Co., Ltd. 951 St.Arbuck St., Fullerton CA
510(k) summary
Statement
Third party review
No

Clearances, product code EIA

Trailing 12 months
2 clearances under product code EIA in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EIA, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260