Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray— 510(k) K150750
Substantially EquivalentSirona Dental Systems GmbH
FDA 510(k) clearance K150750 for Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray, Substantially Equivalent on 2015-07-02. Applicant: Sirona Dental Systems GmbH.
Clearance details
- Applicant
- Sirona Dental Systems GmbH
- Product code
- Code EGS
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bensheim, DE
Adverse events under product code EGS
product code EGS- Injury
- 356
- Malfunction
- 759
- Total
- 1,115
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.