K242261
- 510(k) number
- K242261
- Device name
- Accelx Implant System
- Applicant
- Biotech Dental, LLC NJ · US
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2024-11-06
- Date received
- 2024-07-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K242261.pdf
Official FDA record: K242261
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.