FDA cleared the Cemented Plus Abutment from Unidental Co., Ltd. on Sep 23, 2026 under K262207, a traditional 510(k). The device falls under product code NHA, Abutment, Implant, Dental, Endosseous, regulated at 21 CFR 872.3630 as a Class 2 device. The review panel was Dental.
FDA logged the submission as received on Jun 30, 2026. The decision came 85 days later, inside the 90 FDA-day goal for a 510(k).
This is the only decision on file for Unidental Co., Ltd. in the last 12 months of the tracker.
Questions & Answers
What did FDA clear under K262207?
K262207 is the FDA 510(k) for Cemented Plus Abutment, submitted by Unidental Co., Ltd.. FDA's decision date was Sep 23, 2026, under product code NHA (Abutment, Implant, Dental, Endosseous).
Who makes the Cemented Plus Abutment?
Unidental Co., Ltd., based in Gwangmyeong-Si, is the applicant of record for K262207.
How long did the K262207 review take?
FDA received the submission on Jun 30, 2026 and issued its decision on Sep 23, 2026, 85 days later.