510(k) K251614
- Device
- Stainless Steel Surgical Kits
- Applicant
- Dentsply Sirona, Inc.
- 510(k) number
- K251614
- Product code
- KCT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-02-06
- Date received
- 2025-05-27
- 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
- Laura Sobrin
- Address
- 221 W. Philadelphia St. Suite 60w York PA US 17401 17401
FDA Registration Numbers
- 1423662
- 3013283620
- 3015181082
- 3015895045
- 3026612481
- 3009540749
- 9613348
- 1416980
- 1450428
- 3043164947
- 3010393565
- 3006639944
- 3008517893
- 3011276344
- 3002808270
- 3006948427
- 3012507533
- 3010057495
- 2134470
- 3004464325
- 1421101
- 9680735
- 3010041430
- 3013357025
- 3013188547
- 3001617766
- 9680845
- 3023852420
- 1834331
- 3005741909
- 9612074
- 3009513193
- 3020767943
- 3013177549
- 3004112448
- 2023811
- 1833920
- 3017155536
- 1941138
- 3007695749
- 1058020
- 1319130
- 3034676720
- 3011050570
- 3005071827
- 1043653
- 3013557562
- 9610612
- 3010202439
- 3008791019
- 3011649314
- 1062741
- 2027754
- 9617542
- 3023155873
- 3004976965
- 3008959420
- 3004193466
- 3005004799
- 3010687973
- 1418479
- 2916714
- 1832228
- 3008719017
- 3009968482
- 3036622014
- 8010177
- 2424366
- 3014409963
- 3011533888
- 3027665899
- 3014553709
- 8010099
- 3016438694
- 8020776
- 3006554912
- 2248608
- 3003230618
- 3001082453
- 3006113180
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code KCT
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253791 | PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid | DePuy Mitek, Inc. | 2026-02-26 |
| K251756 | Sterilization Trays | Paragon Implant Mfg., LLC | 2025-11-14 |
| K251300 | Plastic Surgical Kits | Dentsply Sirona, Inc. | 2025-07-22 |
| K243425 | Guided DAS Surgical Kit | Talladium España, SL | 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 |
| K242834 | System 9 Sterile Battery Container | Stryker Instruments | 2025-01-16 |
| K243128 | Klockner Kits | SOADCO, S.L. | 2024-12-18 |
| K241492 | Guided Surgery Kit Cases | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2024-08-23 |
| K240898 | SteriTite rigid reusable sterilization container with MediTray Products | Case Medical | 2024-07-31 |