CEREC Tessera Abutment Block, CEREC Tessera Abutment System— 510(k) K221402
Substantially EquivalentDentsply Sirona, Inc.
FDA 510(k) clearance K221402 for CEREC Tessera Abutment Block, CEREC Tessera Abutment System, Substantially Equivalent on 2023-03-22. Applicant: Dentsply Sirona, Inc..
Clearance details
- Applicant
- Dentsply Sirona, Inc.
- Product code
- Code NHA
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- York, PA, 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.