OCO DENTAL IMPLANT— 510(k) K021460

Substantially Equivalent

O Co., Inc.

FDA 510(k) clearance K021460 for OCO DENTAL IMPLANT, Substantially Equivalent on 2002-05-22. Applicant: O Co., Inc..

Clearance details

Applicant
O Co., Inc.
Product code
Code NHA
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Albuquerque, NM, US
Download summary PDFView 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.