FDA.report

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

Related Records

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)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