FDA.report

510(k) K253758

Device
Dental Cone; Dental Sponge
Applicant
Medizin Produkte Neustadt GmbH (Mpn)
510(k) number
K253758
Product code
OLR
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-18
Date received
2025-11-25
Classification name
Oral Wound Dressing
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Danielle Lindner
Address
Donaustrasse 24 Saal/Donau Bavaria DE 93342 93342

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code OLR

510(k)DeviceApplicantDecision date
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
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
K101769EPISILCamurus AB2011-09-13