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Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours

The Tracker / September 2026 / K261935

510(k) cleared

Surgical and Prosthetic Trays

Dentsply Sirona, Inc. · Sep 4, 2026 · K261935

FDA cleared the Surgical and Prosthetic Trays from Dentsply Sirona, Inc. on Sep 4, 2026 under K261935, a traditional 510(k). The device falls under product code KCT, Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, regulated at 21 CFR 880.6850 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jun 9, 2026. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

Dentsply Sirona, Inc. has 8 other decisions in the tracker over the last 12 months: K262127 (DS Core CBCT Anatomy), K260785 (DS Core CBCT Anatomy), K260722 (SureSmile Aligner (ASSY500020)), K253565 (SureSmile Software).

Questions & Answers

What did FDA clear under K261935?

K261935 is the FDA 510(k) for Surgical and Prosthetic Trays, submitted by Dentsply Sirona, Inc.. FDA's decision date was Sep 4, 2026, under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories).

Who makes the Surgical and Prosthetic Trays?

Dentsply Sirona, Inc., based in York, PA, is the applicant of record for K261935.

How long did the K261935 review take?

FDA received the submission on Jun 9, 2026 and issued its decision on Sep 4, 2026, 87 days later.

← All decisions in September 2026