K3PRO Konus Additional Abutments and Implants— 510(k) K160581
Substantially EquivalentArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG
FDA 510(k) clearance K160581 for K3PRO Konus Additional Abutments and Implants, Substantially Equivalent on 2017-03-24. Applicant: Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG.
Clearance details
- Applicant
- Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG
- Product code
- Code DZE
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bingen Am Rhein, DE
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.