Accelx Implant System— 510(k) K242261
Substantially EquivalentBiotech Dental, LLC
FDA 510(k) clearance K242261 for Accelx Implant System, Substantially Equivalent on 2024-11-06. Applicant: Biotech Dental, LLC.
Clearance details
- Applicant
- Biotech Dental, LLC
- Product code
- Code DZE
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Englewood, NJ, US
Adverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
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.