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The Tracker / September 2026 / K260940

510(k) cleared

BellaTek Bars

ZimVie US Corp, LLC · Sep 21, 2026 · K260940

FDA cleared the BellaTek Bars from ZimVie US Corp, LLC on Sep 21, 2026 under K260940, a special 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 Mar 20, 2026. The decision came 185 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 ZimVie US Corp, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260940?

K260940 is the FDA 510(k) for BellaTek Bars, submitted by ZimVie US Corp, LLC. FDA's decision date was Sep 21, 2026, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the BellaTek Bars?

ZimVie US Corp, LLC, based in Palm Beach Gardens, FL, is the applicant of record for K260940.

How long did the K260940 review take?

FDA received the submission on Mar 20, 2026 and issued its decision on Sep 21, 2026, 185 days later.

← All decisions in September 2026