Guided DAS Surgical Kit
FDA 510(k) K243425 · Talladium España, SL
510(k) numberK243425
Submission
- Device name
- Guided DAS Surgical Kit
- Applicant
- Talladium España, SL
Lleida, ES - Received
- November 4, 2024
- 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 |
| K251300 | Plastic Surgical KitsKCT · Traditional | Dentsply Sirona, Inc. | 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 |
|---|---|---|
| K243732 | Multi-Unit DAS SystemNHA · Traditional | 01/29/2026SE |
| K243530 | Dynamic TiBaseNHA · Traditional | 05/30/2025SE |
| K241170 | Dynamic TiBase; TRI ScrewsNHA · Traditional | 10/21/2024SE |
| K231559 | Multi-Unit DAS SystemNHA · Traditional | 11/17/2023SE |
| K232151 | Dynamic TiBaseNHA · Traditional | 10/17/2023SE |
| K212108 | Dynamic TiBaseNHA · Traditional | 09/24/2021SE |
Questions and answers
When was Guided DAS Surgical Kit cleared by the FDA?
Guided DAS Surgical Kit (K243425) received a 510(k) decision of Substantially Equivalent on July 22, 2025, 260 days after the submission was received.
What is the product code of K243425?
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.