DUO-DENT DENTAL IMPLANT— 510(k) K010386
Substantially EquivalentDuo-Dent Dental Implant Systems, LLC
FDA 510(k) clearance K010386 for DUO-DENT DENTAL IMPLANT, Substantially Equivalent on 2001-02-27. Applicant: Duo-Dent Dental Implant Systems, LLC.
Clearance details
- Applicant
- Duo-Dent Dental Implant Systems, LLC
- Product code
- Code DZE
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Grayslake, IL, 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.