Surgical and Prosthetic Trays— 510(k) K261935
Substantially EquivalentDentsply Sirona, Inc.
FDA 510(k) clearance K261935 for Surgical and Prosthetic Trays, Substantially Equivalent on 2026-09-04. Applicant: Dentsply Sirona, Inc.. Device class: 2.
Summary
Dentsply Sirona's Surgical and Prosthetic Trays are filed under KCT, sterilization wrap containers, trays, cassettes, and other accessories. The record doesn't say which instruments or components the trays hold.
Class II, 21 CFR 880.6850. General Hospital is both the classification panel and the review panel. It came in as a Traditional 510(k).
Dentsply Sirona filed from York, Pennsylvania. The decision came 87 calendar days after receipt (June 9 to September 4, 2026).
Clearance details
- Applicant
- Dentsply Sirona, Inc.
- Product code
- Product code KCT
- Device class
- Class 2
- Regulation
- 21 CFR 880.6850
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- York, PA, US
Recent devices under product code KCT
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