FDA.reportPublic FDA data

510(k) K203091

Device
MucoLock Oral Gel
Applicant
PCCA, Inc.
510(k) number
K203091
Product code
OLR  
Decision
Substantially Equivalent (SESE)
Decision date
2021-02-12
Date received
2020-10-13
Regulation
510(k) Premarket Notification
Classification name
Oral Wound Dressing
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Dental
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Gus Bassani
Address
9901 S. Wilcrest Dr. Houston TX US 77099 77099

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OLR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253816MuCover (proposed name) Oral Wound DressingMoleculeX Co., Ltd.2026-05-21
K253758Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn)2025-12-18
K252425Silatrix Oral GelSa3, LLC2025-10-23
K241283Elemental GranulateZinkh NV2025-01-03
K230529HealiAid Dental Collagen Wound DressingMaxigen Biotech, Inc.2023-11-22
K221428PerioStom Dental DressingForward Science, LLC2022-12-22
K211851Ora-AidTbm Corporation2022-01-11
K210211PuraStat-OM3-D Matrix, Inc.2021-10-08
K202000Silatrix Oral GelSa3, LLC2020-11-20
K193336Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound RinseSynedgen, Inc.2020-05-27
K191987OrapeuticForward Science2019-11-27
K183436OraCureTbm Corporation2019-09-18
K173196SUNTOUCH Dental DressingHuizhou Foryou Medical Devices Co., Ltd.2018-01-24
K130959AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GELBioplax Limited2014-04-04
K112568AONGEN DENTAL COLLAGEN MATRIXAeon Astron Europe B.V.2012-03-01

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases