Plastic Surgical Kits
FDA 510(k) K251300 · Dentsply Sirona, Inc.
510(k) numberK251300
Submission
- Device name
- Plastic Surgical Kits
- Applicant
- Dentsply Sirona, Inc.
York, PA, US - Received
- April 28, 2025
- Decision date
- July 22, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6850
- Specialty
- General Hospital
Other 510(k)s with product code KCT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253988 | LiteSet TraysKCT · Traditional | Nobel Biocare AB | 09/08/2026SE |
| K261935 | Surgical and Prosthetic TraysKCT · Traditional | Dentsply Sirona, Inc. | 09/04/2026SE |
| K253187 | SteriBest® Sterilization Tray SystemKCT · Traditional | Mastel Surgical | 06/18/2026SE |
| K260726 | Straumann® ProClean Cassette (041.800 ; 041.801)KCT · Traditional | Institut Straumann AG | 06/03/2026SE |
| K252854 | SteriTite Container System with MediTray ProductsKCT · Traditional | Case Medical, Inc. | 06/03/2026SE |
| K253791 | PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System LidKCT · Traditional | DePuy Mitek, Inc. | 02/26/2026SE |
| K251614 | Stainless Steel Surgical KitsKCT · Traditional | Dentsply Sirona, Inc. | 02/06/2026SE |
| K251756 | Sterilization TraysKCT · Traditional | Paragon Implant Mfg., LLC | 11/14/2025SE |
| K243425 | Guided DAS Surgical KitKCT · Traditional | Talladium España, SL | 07/22/2025SE |
| K243589 | PAL Sterilization CaseKCT · Traditional | Microaire Surgical Instruments, LLC | 06/20/2025SE |
More from Microaire Surgical Instruments, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K261935 | Surgical and Prosthetic TraysKCT · Traditional | 09/04/2026SE |
| K262127 | DS Core CBCT AnatomyQIH · Traditional | 08/21/2026SE |
| K260785 | DS Core CBCT AnatomyQIH · Traditional | 04/23/2026SE |
| K260722 | SureSmile Aligner (ASSY500020)NXC · Traditional | 04/15/2026SE |
| K253565 | SureSmile SoftwarePNN · Traditional | 03/04/2026SE |
| K251614 | Stainless Steel Surgical KitsKCT · Traditional | 02/06/2026SE |
| K253959 | Primevision 3DOAS · Traditional | 02/05/2026SE |
| K253009 | DS Core DetectMYN · Traditional | 01/07/2026SE |
| K252343 | Atlantis® Abutments in TitaniumNHA · Traditional | 12/09/2025SE |
| K252248 | CEREC Tessera Abutment SystemNHA · Traditional | 11/26/2025SE |
Questions and answers
When was Plastic Surgical Kits cleared by the FDA?
Plastic Surgical Kits (K251300) received a 510(k) decision of Substantially Equivalent on July 22, 2025, 85 days after the submission was received.
What is the product code of K251300?
The FDA product code is KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, a Class II (moderate risk) device regulated under 21 CFR 880.6850.