FDA.reportPublic FDA data

510(k) K252425

Device
Silatrix Oral Gel
Applicant
Sa3, LLC
510(k) number
K252425
Product code
OLR
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-23
Date received
2025-08-01
Classification name
Oral Wound Dressing
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Farbod Melamed
Address
2317 Cotner Ave. Los Angeles CA US 90064 90064

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
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
K203091MucoLock Oral GelPcca, Inc.2021-02-12
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