DeviceClearance

K242064

Substantially Equivalent

Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)

Applicant
Smart Denture Conversions, LLC
Product code
NHA
Advisory panel
Dental
Date received
Decision date
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, through . 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.