ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW— 510(k) K081393

Substantially Equivalent

G & H Wire Co.

FDA 510(k) clearance K081393 for ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW, Substantially Equivalent on 2008-08-21. Applicant: G & H Wire Co..

Clearance details

Applicant
G & H Wire Co.
Product code
Code OAT
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carmel, IN, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code OAT

product code OAT
Injury
355
Total
355

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.