Stainless Steel Surgical Kits— 510(k) K251614
Substantially EquivalentDentsply Sirona, Inc.
FDA 510(k) clearance K251614 for Stainless Steel Surgical Kits, Substantially Equivalent on 2026-02-06. Applicant: Dentsply Sirona, Inc.. Device class: 2.
Summary
Dentsply Sirona filed Stainless Steel Surgical Kits under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories). The name is generic, and the record gives no models or further description.
Class II, 21 CFR 880.6850. General Hospital is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Dentsply Sirona filed from York, Pennsylvania. The decision came 255 calendar days after FDA received it (May 27, 2025 to February 6, 2026), and it was substantially equivalent.
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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