BIO-ESTHETIC INDIRECT ABUTMENT— 510(k) K970073

Name: FDA 510(k) clearance K970073
Creator: U.S. Food and Drug Administration
Published: 1997-07-03

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.. Device class: 2.

Clearance details

Applicant: Steri-Oss, Inc.
Product code: Product code NHA
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 1997-01-08
Decision date: 1997-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorba Linda, CA, US

Download summary PDF View on FDA.gov ↗

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K982400 — STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT1998-09-23
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K973433 — STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT1997-12-05
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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.