ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S]— 510(k) K133791
Substantially EquivalentSterngold Dental, LLC
FDA 510(k) clearance K133791 for ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S], Substantially Equivalent on 2014-04-16. Applicant: Sterngold Dental, LLC.
Clearance details
- Applicant
- Sterngold Dental, LLC
- Product code
- Code NHA
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Attleboro, MA, US
Adverse events under product code NHA
product code NHA- Injury
- 1,270
- Malfunction
- 2,860
- Total
- 4,130
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.