NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)— 510(k) K090630

Substantially Equivalent

Nobel Biocare AB

FDA 510(k) clearance K090630 for NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION), Substantially Equivalent on 2009-06-02. Applicant: Nobel Biocare AB.

Clearance details

Applicant: Nobel Biocare AB
Product code: Code FZE
Advisory panel: General, Plastic Surgery
Date received: 2009-03-09
Decision date: 2009-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorba Linda,, CA, US

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Adverse events under product code FZE

product code FZE

Injury: 138
Total: 138

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.