MAJOR.REPAIR— 510(k) K082153
Substantially EquivalentMajor Prodotti Dentari S.P.A.
FDA 510(k) clearance K082153 for MAJOR.REPAIR, Substantially Equivalent on 2008-11-25. Applicant: Major Prodotti Dentari S.P.A..
Clearance details
- Applicant
- Major Prodotti Dentari S.P.A.
- Product code
- Code EBI
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Monacalieri (Torino), IT
Adverse events under product code EBI
product code EBI- Other
- 1
- Total
- 1
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.