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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 / K261888

510(k) cleared

ClearClub Impression Material

ClearClub · Sep 16, 2026 · K261888

FDA cleared the ClearClub Impression Material from ClearClub on Sep 16, 2026 under K261888, a traditional 510(k). The device falls under product code SHI, Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter, regulated at 21 CFR 872.3660 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jun 5, 2026. The decision came 103 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for ClearClub in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261888?

K261888 is the FDA 510(k) for ClearClub Impression Material, submitted by ClearClub. FDA's decision date was Sep 16, 2026, under product code SHI (Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter).

Who makes the ClearClub Impression Material?

ClearClub, based in Inglewood, CA, is the applicant of record for K261888.

How long did the K261888 review take?

FDA received the submission on Jun 5, 2026 and issued its decision on Sep 16, 2026, 103 days later.

← All decisions in September 2026