Legacy SMARTBase Abutments— 510(k) K191458

Name: FDA 510(k) clearance K191458
Creator: U.S. Food and Drug Administration
Published: 2019-10-10

Substantially Equivalent

Implant Direct Sybron Manufacturing, LLC

FDA 510(k) clearance K191458 for Legacy SMARTBase Abutments, Substantially Equivalent on 2019-10-10. Applicant: Implant Direct Sybron Manufacturing, LLC. Device class: 2.

Clearance details

Applicant: Implant Direct Sybron Manufacturing, LLC
Product code: Code NHA
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2019-05-31
Decision date: 2019-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thousand Oaks, CA, US

Download summary PDF View on FDA.gov ↗

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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.