510(k) K242023

Device
Microdent Sterilization Cassette
Applicant
Implant Microdent System S.L.U.
510(k) number
K242023
Product code
KCT
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-19
Date received
2024-07-11
Regulation
880.6850
Classification name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Joan Muñoz
Address
C/Carles Bu"Igues, 1 1 Pol. Ind. Can Magre Santa Eulalia De Ronçana ES 08187 08187

FDA Registration Numbers

Source Documents

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

Other 510(k) Records For Product Code KCT

510(k)DeviceApplicantDecision date
K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.2026-02-26
K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.2026-02-06
K251756Sterilization TraysParagon Implant Mfg., LLC2025-11-14
K251300Plastic Surgical KitsDentsply Sirona, Inc.2025-07-22
K243425Guided DAS Surgical KitTalladium España, SL2025-07-22
K243589PAL Sterilization CaseMicroaire Surgical Instruments, LLC2025-06-20
K242762Aesculap Aicon® Series Container SystemAesculap, Inc.2025-05-13
K250029ONE TRAY® Sealed Sterilization Container SystemInnovative Sterilization Technologies2025-05-01
K241927Synthes Graphic Case & Tray SystemSynthes GmbH2025-03-28
K242564Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)Prismatik Dentalcraft, Inc.2025-03-21
K243317NUVENTUS NV.C™ Surgical Cassette and TrayInfinitum Eta, Ltd.2025-02-11
K242834System 9 Sterile Battery ContainerStryker Instruments2025-01-16
K243128Klockner KitsSOADCO, S.L.2024-12-18
K241492Guided Surgery Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.2024-08-23
K240898SteriTite rigid reusable sterilization container with MediTray ProductsCase Medical2024-07-31