FDA.reportPublic FDA data

510(k) K254239

Device
CyClean Cord
Applicant
SS GLOBAL
510(k) number
K254239
Product code
MVL
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-27
Date received
2025-12-29
Classification name
Cord, Retraction
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Jun Hwan Ahn
Address
101-#304, Chunui-Technopark, 36, Bucheon-Ro 198 Beon-Gil Bucheon-Si KR 14557 14557

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MVL#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253797One-StopMediclus Co., Ltd.2026-02-27
K243910RetraxilKulzer, LLC2025-09-24
K211420Stasis GelBelport Company, Inc., Gingi-Pak2022-03-14
K211419Gingi-Aid GelBelport Company, Inc., Gingi-Pak2022-01-10
K213149VOCO Retraction PasteVoco GmbH2021-12-09
K200764STATSTIXCentrix Incorporated2020-10-15
K193389Vista ClearInter-Med/Vista Dental Products2020-03-04
K190220Vista FS, Vista FS LiquidInter-Med/Vista Dental Products2019-06-10
K171577Smartcord, Smartcord XEastdent Co., Ltd.2018-05-03
K162662GingiDent Gingival Retraction PastePac-Dent International, Inc.2017-10-20
K162948Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/MaterialsKerr Corporation2017-08-08
K162536GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction CordKerr Corporation2017-02-03
K162164GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction CordKerr Corporation2017-01-13
K152064Astringedent ClearUltradent Products, Inc.2015-09-24
K150423EXPAZENProduits Dentaires Pierre Rolland (Acteon Group)2015-07-08