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#
- 3003935342
- 3014409963
- 3011824442
- 3005071827
- 3008135745
- 3006948427
- 3026606306
- 3013357025
- 3010687973
- 3010041511
- 3012236936
- 3043543260
- 3019878714
- 2020550
- 3004464325
- 3010120135
- 3006179046
- 3013188547
- 9680718
- 1221934
- 9617111
- 1423662
- 9681851
- 3009538923
- 1835251
- 3010885402
- 3003236702
- 1223422
- 3017155536
- 1032347
- 3010202439
- 3015967359
- 3023852420
- 3008719017
- 3027345187
- 1833920
- 9612074
- 2027754
- 3014967149
- 3010684280
- 8044099
- 1421879
- 1717344
- 2020601
- 3012085539
- 8020776
- 3010772758
- 3005360851
- 2084725
- 3011276344
- 9610617
- 9611367
- 3002259632
- 3017949824
- 9614404
- 3011373951
- 9710524
- 3013111692
- 3000270450
- 3011577940
- 3003418325
- 3011063460
- 3018094310
- 3015612252
- 3015895045
- 3009540749
- 8030607
- 3006561161
- 1314417
- 9611959
- 3007367732
- 3015224777
- 3008517893
- 3015960676
- 3009539885
- 3010393565
- 1017294
- 1058584
- 8010697
- 3008309062
Source Documents#
Other 510(k) Records For Product Code KCT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253988 | LiteSet Trays | Nobel Biocare AB | 2026-09-08 |
| 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 |