FDA.reportPublic FDA data

510(k) K230529

Device
HealiAid Dental Collagen Wound Dressing
Applicant
Maxigen Biotech, Inc.
510(k) number
K230529
Product code
OLR
Decision
Substantially Equivalent (SESE)
Decision date
2023-11-22
Date received
2023-02-27
Classification name
Oral Wound Dressing
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Cheng-Han Zhou
Address
#88, Keji 1st Rd., Guishan Dist., Taoyuan TW 33383 33383

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
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