Product Code: MVL FDA unclassified

Cord, Retraction

Unknown

A Retraction Cord is a dental device, typically made of braided cotton fibers, inserted into the gingival sulcus around a prepared tooth to temporarily displace and retract gingival tissue and control fluid, providing a clear field for impression taking or other restorative procedures. This device has an unclassified status (class "U") in the FDA database. The product code is MVL with no regulation number assigned, and the device is not an implant and is not life-sustaining.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MVL
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 36 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K254239	CyClean Cord	Mar 27, 2026	Substantially Equivalent	SS GLOBAL
K253797	One-Stop	Feb 27, 2026	Substantially Equivalent	Mediclus Co., Ltd.
K243910	Retraxil	Sep 24, 2025	Substantially Equivalent	Kulzer, LLC
K211420	Stasis Gel	Mar 14, 2022	Substantially Equivalent	Belport Company, Inc., Gingi-Pak
K211419	Gingi-Aid Gel	Jan 10, 2022	Substantially Equivalent	Belport Company, Inc., Gingi-Pak
K213149	VOCO Retraction Paste	Dec 09, 2021	Substantially Equivalent	Voco GmbH
K200764	STATSTIX	Oct 15, 2020	Substantially Equivalent	Centrix Incorporated
K193389	Vista Clear	Mar 04, 2020	Substantially Equivalent	Inter-Med/Vista Dental Products
K190220	Vista FS, Vista FS Liquid	Jun 10, 2019	Substantially Equivalent	Inter-Med/Vista Dental Products
K171577	Smartcord, Smartcord X	May 03, 2018	Substantially Equivalent	Eastdent Co., Ltd.
K162662	GingiDent Gingival Retraction Paste	Oct 20, 2017	Substantially Equivalent	Pac-Dent International, Inc.
K162948	Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials	Aug 08, 2017	Substantially Equivalent	Kerr Corporation
K162536	GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord	Feb 03, 2017	Substantially Equivalent	Kerr Corporation
K162164	GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord	Jan 13, 2017	Substantially Equivalent	Kerr Corporation
K152064	Astringedent Clear	Sep 24, 2015	Substantially Equivalent	Ultradent Products, Inc.
K150423	EXPAZEN	Jul 08, 2015	Substantially Equivalent	Produits Dentaires Pierre Rolland (Acteon Group)
K130580	RETRACTION PASTE	Feb 25, 2014	Substantially Equivalent	Dmg USA, Inc.
K131799	QUICKNIT	Jan 16, 2014	Substantially Equivalent	Microcopy, Div. of Neo-Flo, Inc.
K132526	KNIT-PAK+	Nov 26, 2013	Substantially Equivalent	Premier Dental Products Co.
K123215	VISCOSTAT CLEAR	Feb 05, 2013	Substantially Equivalent	Ultradent Products, Inc.
K113839	RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE	Apr 12, 2012	Substantially Equivalent	Parkell, Inc.
K111978	SULCUS BLUE	Oct 13, 2011	Substantially Equivalent	Produits Dentaires Pierre Rolland
K111348	RE / STASIS (TM) GINGIVAL RETRACTION PASTE	Jul 22, 2011	Substantially Equivalent	Centrix, Inc.
K101756	TSC	Oct 26, 2010	Substantially Equivalent	Kerr Corporation
K102133	GIRAFFE2	Oct 07, 2010	Substantially Equivalent	Kerr Corporation
K093721	COSP2	Feb 19, 2010	Substantially Equivalent	3M Espe AG Dental Products
K093711	RACEGEL	Feb 17, 2010	Substantially Equivalent	Septodont
K092384	LIQUICORD	Nov 04, 2009	Substantially Equivalent	Centrix, Inc.
K091380	CORDCAP	Jul 30, 2009	Substantially Equivalent	Centrix, Inc.
K083695	TRAXODENT	Apr 28, 2009	Substantially Equivalent	Premier Dental Products Co.
K082116	HEMOSTASYL PASTE	Dec 17, 2008	Substantially Equivalent	Satelec
K053329	KORLEX-GR GINGIVAL RETRACTION PASTE	Feb 15, 2006	Substantially Equivalent	Biotech One, Inc.
K050180	EXPA-SYL	Feb 11, 2005	Substantially Equivalent	Produits Dentaires Pierre Rolland
K041023	STAY-PUT IMPREGNATED	Jun 15, 2004	Substantially Equivalent	Coltene/Whaledent GmbH & Co. KG
K010070	ULTRAPAK NEHA	Mar 15, 2001	Substantially Equivalent	Ultradent Products, Inc.
K981596	ULTRAPAK E	Jul 31, 1998	Substantially Equivalent	Ultradent Products, Inc.