BellaTek Bars— 510(k) K260940
Substantially EquivalentZimVie US Corp, LLC
FDA 510(k) clearance K260940 for BellaTek Bars, Substantially Equivalent on 2026-09-21. Applicant: ZimVie US Corp, LLC. Device class: 2.
Summary
BellaTek Bars from ZimVie US Corp, LLC are filed under NHA, endosseous dental implant abutments. The record doesn't describe the bars beyond the name and code.
Class II, 21 CFR 872.3630, Dental panel. ZimVie filed it as a Special 510(k).
ZimVie filed from Palm Beach Gardens, Florida. Review took 185 days (March 20 to September 21, 2026). The record doesn't explain the length of the clock.
Clearance details
- Applicant
- ZimVie US Corp, LLC
- Product code
- Product code NHA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3630
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Palm Beach Gardens, FL, US
Recent devices under product code NHA
view allAdverse events under product code NHA
product code NHA- Injury
- 1,270
- Malfunction
- 2,860
- Total
- 4,130
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.