510(k) K250029
- Device
- ONE TRAY® Sealed Sterilization Container System
- Applicant
- Innovative Sterilization Technologies
- 510(k) number
- K250029
- Product code
- KCT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-01
- Date received
- 2025-01-06
- 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
Applicant Contact#
- Contact
- Walter Oko
- Address
- 7625 Paragon Rd. Dayton OH US 45459 45459
FDA Registration Numbers#
- 1935627
- 3013557562
- 3042624965
- 1032347
- 9710524
- 3027345187
- 3004464325
- 3006639944
- 3012322232
- 1926681
- 3014967149
- 3016607092
- 3021336392
- 3003236702
- 1223422
- 3023155873
- 3007695749
- 3003935342
- 2518634
- 3008812560
- 1720499
- 8040233
- 1717344
- 3014003062
- 1416980
- 3003394627
- 1221934
- 3017820152
- 3015895045
- 1421101
- 3004080920
- 3026606306
- 2031966
- 9611274
- 3013283620
- 3013357025
- 3001082453
- 3002808270
- 9617542
- 3008135745
- 3005071827
- 1030489
- 3014409963
- 1056553
- 3008770252
- 3020767943
- 3015537048
- 3005497913
- 3004153240
- 1526531
- 3004112448
- 3011050570
- 3006554912
- 3015224777
- 3014191428
- 1836161
- 3012507533
- 3010363542
- 3003604053
- 3006846433
- 3009307953
- 9610612
- 3005706667
- 1417592
- 3013077751
- 2248608
- 3006948427
- 3016438694
- 1226230
- 3004193466
- 3010041430
- 8030607
- 9610773
- 9612074
- 3012236936
- 3015392401
- 3015612252
- 3003418325
- 3008719017
- 1319130
Source Documents#
Other 510(k) Records For Product Code KCT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262042 | Sterilization Cassette (CASS-1) | Alliedstar Medical Equipment Co., Ltd. | 2026-10-14 |
| K253988 | LiteSet Trays | Nobel Biocare AB | 2026-09-08 |
| K261935 | Surgical and Prosthetic Trays | Dentsply Sirona, Inc. | 2026-09-04 |
| K253187 | SteriBest® Sterilization Tray System | Mastel Surgical | 2026-06-18 |
| K252854 | SteriTite Container System with MediTray Products | Case Medical, Inc. | 2026-06-03 |
| K260726 | Straumann® ProClean™ Cassette (041.800 ; 041.801) | Institut Straumann AG | 2026-06-03 |
| K253791 | PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid | DePuy Mitek, Inc. | 2026-02-26 |
| K251614 | Stainless Steel Surgical Kits | Dentsply Sirona, Inc. | 2026-02-06 |
| K251756 | Sterilization Trays | Paragon Implant Mfg., LLC | 2025-11-14 |
| K243425 | Guided DAS Surgical Kit | Talladium España, SL | 2025-07-22 |
| K251300 | Plastic Surgical Kits | Dentsply Sirona, Inc. | 2025-07-22 |
| K243589 | PAL Sterilization Case | Microaire Surgical Instruments, LLC | 2025-06-20 |
| K242762 | Aesculap Aicon® Series Container System | Aesculap, Inc. | 2025-05-13 |
| K241927 | Synthes Graphic Case & Tray System | Synthes GmbH | 2025-03-28 |
| K242564 | Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit) | Prismatik Dentalcraft, Inc. | 2025-03-21 |