510(k) clearance

BellaTek Bars

FDA 510(k) source

510(k) number

K260940

Applicant

ZimVie US Corp, LLC

Decision date

Sep 21, 2026

Date received

Mar 20, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

NHA

Device type

Abutment, Implant, Dental, Endosseous

Device class

Class II

Regulation

21 CFR 872.3630

Advisory committee

Dental

Statement or summary

Summary

Third party

N

Location

Palm Beach Gardens, FL, US