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510(k) K193336

Device
Synvaza Mouth Sore And Wound Rinse, Synvaza II Mouth Sore And Wound Rinse
Applicant
Synedgen, Inc.
510(k) number
K193336
Product code
OLR  
Decision
Substantially Equivalent (SESE)
Decision date
2020-05-27
Date received
2019-12-02
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
Shenda Baker
Address
1420 N. Claremont Blvd. Suite 105d Claremont CA US 91711 91711

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
K203091MucoLock Oral GelPcca, Inc.2021-02-12
K202000Silatrix Oral GelSa3, LLC2020-11-20
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#

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FDA Review#

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