510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K180953Substantially Equivalent

AnyCheck IMT-100

Dms Co., Ltd., Wonju-Si, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180953 is the FDA 510(k) clearance record for AnyCheck IMT-100, a class I device, cleared for Dms Co., Ltd. on under FDA product code EKX (Handpiece, Direct Drive, Ac-Powered). FDA records list one 510(k) clearance for Dms Co., Ltd. As of , FDA records show no recalls naming K180953.

Clearance record

Decision date
Received
(315 days to decision)
Product code
EKX Handpiece, Direct Drive, Ac-Powered
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
Dms Co., Ltd. #201 #202 & #204, Oriental Medical Industry, Wonju-Si, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EKX

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