510(k) K253187
- Device
- SteriBest® Sterilization Tray System
- Applicant
- Mastel Surgical
- 510(k) number
- K253187
- Product code
- KCT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-18
- Date received
- 2025-09-26
- 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
- Patrick Haney
- Address
- 1550 Samco Rd. Rapid City SD US 57702 57702
FDA Registration Numbers#
- 3013546462
- 3005497913
- 3010057495
- 3006561161
- 2027467
- 9611959
- 3006846433
- 3038549074
- 2248608
- 3006639944
- 3010707607
- 2031966
- 3005900820
- 3015895145
- 3015612252
- 1320894
- 3014615028
- 3015224777
- 3034676720
- 1834331
- 1222780
- 1416980
- 3007695749
- 3015153469
- 3009539885
- 3008719017
- 3006783837
- 3012085539
- 3013283620
- 1057421
- 3011533888
- 3024788684
- 3015336263
- 1926681
- 2936485
- 3004215117
- 2518634
- 2020394
- 3026606306
- 1723170
- 1221934
- 2424366
- 3003236702
- 3005083075
- 3014409963
- 2431166
- 3004153240
- 3003477135
- 3043164947
- 9616024
- 9710524
- 3001082453
- 3011050570
- 3004491689
- 3001675293
- 3013077751
- 3027665899
- 9611367
- 3026612481
- 1526534
- 3019878714
- 3003418325
- 1032347
- 3009050824
- 8030607
- 3038718579
- 3012055599
- 3015895045
- 3011063460
- 9611102
- 3017619652
- 9610617
- 3014553709
- 3011824442
- 3013247477
- 3014290448
- 3015392401
- 3004464325
- 3014421917
- 1421879
Source Documents#
Other 510(k) Records For Product Code KCT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261935 | Surgical and Prosthetic Trays | Dentsply Sirona, Inc. | 2026-09-04 |
| 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 |
| K250029 | ONE TRAY® Sealed Sterilization Container System | Innovative Sterilization Technologies | 2025-05-01 |
| 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 |
| K242023 | Microdent Sterilization Cassette | Implant Microdent System S.L.U. | 2025-02-19 |
| K243317 | NUVENTUS NV.C™ Surgical Cassette and Tray | Infinitum Eta, Ltd. | 2025-02-11 |