FDA 510(k) Applications for Medical Device Product Code: OLR (Oral Wound Dressing)

FDA 510(k) Applications for Medical Device Product Code "OLR"
(Oral Wound Dressing)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K210211	3-D Matrix, Inc.	PuraStat-OM	10/08/2021
K062795	ACCESS PHARMACEUTICALS, INC	MUGARD MUCOADHESIVE ORAL WOUND RINSE	12/11/2006
K112568	AEON ASTRON EUROPE B.V.	AONGEN DENTAL COLLAGEN MATRIX	03/01/2012
K130959	BIOPLAX LIMITED	AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL	04/04/2014
K081372	BMG PHARMA LLC.	GELX ORAL GEL	02/04/2009
K101769	CAMURUS AB	EPISIL	09/13/2011
K983182	CARRINGTON LABORATORIES, INC.	ALOE THERAPY ORAL RINSE	12/10/1998
K964852	CARRINGTON LABORATORIES, INC.	RADIACARE ORAL WOUND RINSE	03/03/1997
K012126	CARRINGTON LABORATORIES, INC.	THE SALICEPT ORAL PATCH	10/03/2001
K191987	Forward Science	Orapeutic	11/27/2019
K221428	Forward Science LLC	PerioStom Dental Dressing	12/22/2022
K060363	HEMCON, INC.	HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12	07/07/2006
K173196	Huizhou Foryou Medical Devices Co., Ltd.	SUNTOUCH Dental Dressing	01/24/2018
K103054	IZUN PHARMACEUTICALS CORPORATION	PERIOPATCH	02/07/2011
K230529	Maxigen Biotech Inc.	HealiAid Dental Collagen Wound Dressing	11/22/2023
K063148	MERLIN GROUP DBA MCMERLIN DENTAL COMPANY	SOCK IT! ORAL PAIN GEL	01/17/2007
K110750	MIS IMPLANTS TECHNOLOGIES LTD.	PERIOPATCH	04/28/2011
K060340	MPM MEDICAL, INC.	ORAMAGIC PLUS ORAL WOUND RINSE	05/10/2006
K024180	MPM MEDICAL, INC.	ORAMAGICRX ORAL WOUND RINSE	03/14/2003
K203091	PCCA, Inc.	MucoLock Oral Gel	02/12/2021
K082553	REXADERM, INC.	REXASTOM ORAL EASE	11/21/2008
K053342	RICERFARMA SRL	GENGIGEL MOUTHRINSE	03/13/2007
K202000	SA3, LLC	Silatrix Oral Gel	11/20/2020
K040950	SINCLAIR PHARMACEUTICALS, LTD.	ALOCLAIR ORAL GEL	06/21/2004
K023155	SINCLAIR PHARMACEUTICALS, LTD.	ALOCLAIR ORAL RINSE	11/25/2002
K042722	SINCLAIR PHARMACEUTICALS, LTD.	ALOCLAIR ORAL SPRAY	01/13/2005
K013056	SINCLAIR PHARMACEUTICALS, LTD.	GELCLAIR CONCENTRATED ORAL GEL	12/21/2001
K070842	SUNSHINE INTERNATIONAL GROUP, INC.	ULCELOOCIN ORAL ULCER PATCH	06/07/2007
K193336	Synedgen, Inc.	Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse	05/27/2020
K211851	TBM Corporation	Ora-Aid	01/11/2022
K183436	TBM Corporation	OraCure	09/18/2019
K090612	UNICARE BIOMEDICAL	BENACEL	07/24/2009
K241283	Zinkh NV	Elemental Granulate	01/03/2025

FDA 510(k) Applications for Medical Device Product Code "OLR" (Oral Wound Dressing)

FDA 510(k) Applications for Medical Device Product Code "OLR"
(Oral Wound Dressing)