CARBON FIBER BRIDGE, MODEL 28757— 510(k) K031070

Substantially Equivalent

Nobel Biocare AB

FDA 510(k) clearance K031070 for CARBON FIBER BRIDGE, MODEL 28757, Substantially Equivalent on 2003-07-03. Applicant: Nobel Biocare AB.

Clearance details

Applicant: Nobel Biocare AB
Product code: Code EBI
Advisory panel: Dental
Date received: 2003-04-04
Decision date: 2003-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorba Linda, CA, US

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Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

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.