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FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home

The Tracker / September 2026 / K262073

510(k) cleared

Hygienic Protective Bite Cover (2207-010-50)

Dürr Dental SE · Sep 17, 2026 · K262073

FDA cleared the Hygienic Protective Bite Cover (2207-010-50) from Dürr Dental SE on Sep 17, 2026 under K262073, a traditional 510(k). The device falls under product code PEM, Dental Barriers And Sleeves, regulated at 21 CFR 878.4370 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jun 22, 2026. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Dürr Dental SE in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262073?

K262073 is the FDA 510(k) for Hygienic Protective Bite Cover (2207-010-50), submitted by Dürr Dental SE. FDA's decision date was Sep 17, 2026, under product code PEM (Dental Barriers And Sleeves).

Who makes the Hygienic Protective Bite Cover (2207-010-50)?

Dürr Dental SE, based in Bietigheim-Bissingen, is the applicant of record for K262073.

How long did the K262073 review take?

FDA received the submission on Jun 22, 2026 and issued its decision on Sep 17, 2026, 87 days later.

← All decisions in September 2026