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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K261956

510(k) cleared

Dental Barriers and Sleeves (AB0006)

ANI Co., Ltd. · Sep 8, 2026 · K261956

FDA cleared the Dental Barriers and Sleeves (AB0006) from ANI Co., Ltd. on Sep 8, 2026 under K261956, 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 11, 2026. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for ANI Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261956?

K261956 is the FDA 510(k) for Dental Barriers and Sleeves (AB0006), submitted by ANI Co., Ltd.. FDA's decision date was Sep 8, 2026, under product code PEM (Dental Barriers And Sleeves).

Who makes the Dental Barriers and Sleeves (AB0006)?

ANI Co., Ltd., based in Suwon-Si, Gyeonggi-Do, is the applicant of record for K261956.

How long did the K261956 review take?

FDA received the submission on Jun 11, 2026 and issued its decision on Sep 8, 2026, 89 days later.

← All decisions in September 2026