Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut)— 510(k) K242064

Substantially Equivalent

Smart Denture Conversions, LLC

FDA 510(k) clearance K242064 for Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut), Substantially Equivalent on 2025-01-17. Applicant: Smart Denture Conversions, LLC.

Clearance details

Applicant: Smart Denture Conversions, LLC
Product code: Code NHA
Advisory panel: Dental
Date received: 2024-07-15
Decision date: 2025-01-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Apex, NC, US

Download summary PDF View on FDA.gov ↗

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.