Mini Sterilizable Tray
FDA 510(k) K200858 · Implant Direct Sybron Manufacturing, LLC
510(k) numberK200858
Submission
- Device name
- Mini Sterilizable Tray
- Applicant
- Implant Direct Sybron Manufacturing, LLC
Thousand Oaks, CA, US - Received
- April 1, 2020
- Decision date
- August 6, 2020
- 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 |
| K243425 | Guided DAS Surgical KitKCT · Traditional | Talladium España, SL | 07/22/2025SE |
More from Talladium España, SL
| 510(k) | Device | Decision |
|---|---|---|
| K231087 | Guided Surgery KitDZI · Traditional | 08/16/2023SE |
| K223535 | SMARTbase Abutment SystemNHA · Traditional | 06/20/2023SE |
| K222211 | Implant Direct Dental Implant Systems Portfolio - MR ConditionalDZE · Traditional | 02/02/2023SE |
| K202524 | Standard Sterilizable TrayKCT · Traditional | 01/28/2021SE |
| K201553 | Simply Iconic ImplantsDZE · Traditional | 01/22/2021SE |
| K200265 | Surgical DrillsDZI · Traditional | 06/30/2020SE |
| K192221 | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2…DZE · Traditional | 06/25/2020SE |
| K192218 | Custom Legacy and Custom InterActive Titanium AbutmentsNHA · Traditional | 05/08/2020SE |
| K191458 | Legacy SMARTBase AbutmentsNHA · Traditional | 10/10/2019SE |
| K181359 | InterActive SMARTBase AbutmentsNHA · Traditional | 08/15/2018SE |
Questions and answers
When was Mini Sterilizable Tray cleared by the FDA?
Mini Sterilizable Tray (K200858) received a 510(k) decision of Substantially Equivalent on August 6, 2020, 127 days after the submission was received.
What is the product code of K200858?
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.