FDA 510(k) Applications for Medical Device Product Code "MVL"
(Cord, Retraction)

FDA 510(k) Number Applicant Device Name Decision Date
K093721 3M ESPE AG DENTAL PRODUCTS COSP2 02/19/2010
K211419 Belport Company, Inc., Gingi-Pak Gingi-Aid Gel 01/10/2022
K211420 Belport Company, Inc., Gingi-Pak Stasis Gel 03/14/2022
K053329 BIOTECH ONE, INC. KORLEX-GR GINGIVAL RETRACTION PASTE 02/15/2006
K200764 Centrix Incorporated STATSTIX 10/15/2020
K091380 CENTRIX, INC. CORDCAP 07/30/2009
K092384 CENTRIX, INC. LIQUICORD 11/04/2009
K111348 CENTRIX, INC. RE / STASIS (TM) GINGIVAL RETRACTION PASTE 07/22/2011
K041023 COLTENE/WHALEDENT GMBH & CO. KG STAY-PUT IMPREGNATED 06/15/2004
K130580 DMG USA, INC. RETRACTION PASTE 02/25/2014
K171577 EASTDENT Co., Ltd Smartcord, Smartcord X 05/03/2018
K193389 Inter-Med / Vista Dental Products Vista Clear 03/04/2020
K190220 Inter-Med / Vista Dental Products Vista FS, Vista FS Liquid 06/10/2019
K162164 KERR CORPORATION GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord 01/13/2017
K162536 KERR CORPORATION GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord 02/03/2017
K102133 KERR CORPORATION GIRAFFE2 10/07/2010
K162948 KERR CORPORATION Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials 08/08/2017
K101756 KERR CORPORATION TSC 10/26/2010
K131799 MICROCOPY, DIV. OF NEO-FLO INC. QUICKNIT 01/16/2014
K162662 PAC-DENT INTERNATIONAL, INC. GingiDent Gingival Retraction Paste 10/20/2017
K113839 PARKELL, INC. RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE 04/12/2012
K132526 PREMIER DENTAL PRODUCTS CO. KNIT-PAK+ 11/26/2013
K083695 PREMIER DENTAL PRODUCTS CO. TRAXODENT 04/28/2009
K050180 PRODUITS DENTAIRES PIERRE ROLLAND EXPA-SYL 02/11/2005
K111978 PRODUITS DENTAIRES PIERRE ROLLAND SULCUS BLUE 10/13/2011
K150423 PRODUITS DENTAIRES PIERRE ROLLAND (ACTEON GROUP) EXPAZEN 07/08/2015
K082116 SATELEC HEMOSTASYL PASTE 12/17/2008
K093711 SEPTODONT RACEGEL 02/17/2010
K152064 ULTRADENT PRODUCTS, INC. Astringedent Clear 09/24/2015
K981596 ULTRADENT PRODUCTS, INC. ULTRAPAK E 07/31/1998
K010070 ULTRADENT PRODUCTS, INC. ULTRAPAK NEHA 03/15/2001
K123215 ULTRADENT PRODUCTS, INC. VISCOSTAT CLEAR 02/05/2013
K213149 Voco GmbH VOCO Retraction Paste 12/09/2021


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