Cleared Special

K260940 - BellaTek Bars

K260940 is an FDA 510(k) clearance for BellaTek Bars, manufactured by ZimVie US Corp, LLC. The device is a Class 2 Dental device with product code NHA cleared through the Special 510(k) pathway after a 185-day FDA review.

K260940 · ZimVie US Corp, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
185d
Days
Class 2
Risk

K260940 is an FDA 510(k) clearance for the BellaTek Bars. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by ZimVie US Corp, LLC (Palm Beach Gardens, US). The FDA issued a Cleared decision on September 21, 2026 after a review of 185 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all ZimVie US Corp, LLC devices

FDA 510(k) Submission Details - K260940

510(k) Number K260940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2026
Decision Date September 21, 2026
Days to Decision 185 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 128d · This submission: 185d
Pathway characteristics
Modification to existing cleared device.

NHA Device Classification - Class 2, Special Controls

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NHA Abutment, Implant, Dental, Endosseous

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