K251660
- 510(k) number
- K251660
- Device name
- T3 Pro Implants ZimVie Packaging System
- Applicant
- Biomet 3i, LLC FL · US
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2025-06-27
- Date received
- 2025-05-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251660.pdf
Official FDA record: K251660
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.