Ormco Spark Aligner System— 510(k) K182826
Substantially EquivalentSybron Dental Specialties
FDA 510(k) clearance K182826 for Ormco Spark Aligner System, Substantially Equivalent on 2018-10-11. Applicant: Sybron Dental Specialties.
Clearance details
- Applicant
- Sybron Dental Specialties
- Product code
- Code NXC
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orange, CA, US
Adverse events under product code NXC
product code NXC- Injury
- 15,206
- Malfunction
- 2,576
- Other
- 9
- Total
- 17,791
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.