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FDA 510(k)

Stainless Steel Surgical Kits

K-Number: K251614 · 2026-02-06

ApplicantDentsply Sirona, Inc.
Decision Date2026-02-06
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Stainless Steel Surgical Kits is a medical device manufactured by Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2026-02-06 under approval number K251614. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stainless Steel Surgical Kits?

Stainless Steel Surgical Kits is a medical device that received FDA 510(k) clearance on 2026-02-06. It is manufactured by Dentsply Sirona, Inc.. The 510(k) number is K251614.

When was Stainless Steel Surgical Kits approved by the FDA?

Stainless Steel Surgical Kits received FDA 510(k) clearance on 2026-02-06, under approval number K251614.

What company makes Stainless Steel Surgical Kits?

Stainless Steel Surgical Kits is manufactured by Dentsply Sirona, Inc..

What is the FDA product code for Stainless Steel Surgical Kits?

The FDA product code for Stainless Steel Surgical Kits is KCT.

Related Clinical Trials

NCT07212855 Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge Protocol COMPLETED NCT07526805 Digital Manufacturing and Periodontal Performance of CAD/CAM-Customized Orthodontic Molar Bands Compared With Standard Stainless-Steel Bands COMPLETED NCT07523776 Vertical Dimension Changes After Bioflx vs Stainless Steel Crowns in Primary Molars NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41265798 Comparison of two models of biofilm formation on reusable stainless steel medical device material. The Journal of hospital infection (2026)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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