BIO-ESTHETIC INDIRECT ABUTMENT— 510(k) K970073

Substantially Equivalent

Steri-Oss, Inc.

FDA 510(k) clearance K970073 for BIO-ESTHETIC INDIRECT ABUTMENT, Substantially Equivalent on 1997-07-03. Applicant: Steri-Oss, Inc..

Clearance details

Applicant: Steri-Oss, Inc.
Product code: Code NHA
Advisory panel: Dental
Date received: 1997-01-08
Decision date: 1997-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorba Linda, CA, US

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Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

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.