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510(k) K770590

Device
SURGI-KIT
Applicant
ETHOX CORP.
510(k) number
K770590
Product code
KCT  
Decision
Substantially Equivalent (SESE)
Decision date
1977-04-14
Date received
1977-03-28
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
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KCT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253988LiteSet TraysNobel Biocare AB2026-09-08
K261935Surgical and Prosthetic TraysDentsply Sirona, Inc.2026-09-04
K253187SteriBest® Sterilization Tray SystemMastel Surgical2026-06-18
K252854SteriTite Container System with MediTray ProductsCase Medical, Inc.2026-06-03
K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG2026-06-03
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
K243425Guided DAS Surgical KitTalladium España, SL2025-07-22
K251300Plastic Surgical KitsDentsply Sirona, Inc.2025-07-22
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

Legacy Summary#

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FDA Review#

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