NobelProcera Zirconia N1 Base— 510(k) K220048

Substantially Equivalent

Nobel Biocare Services AG

FDA 510(k) clearance K220048 for NobelProcera Zirconia N1 Base, Substantially Equivalent on 2022-07-29. Applicant: Nobel Biocare Services AG.

Clearance details

Applicant
Nobel Biocare Services AG
Product code
Code NHA
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Kloten, CH
Download summary PDFView on FDA.gov ↗

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.