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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