Mini Screws— 510(k) K231502

Substantially Equivalent

Proimtech Saglik Urunleri Anonim Sirketi

FDA 510(k) clearance K231502 for Mini Screws, Substantially Equivalent on 2024-09-04. Applicant: Proimtech Saglik Urunleri Anonim Sirketi.

Clearance details

Applicant
Proimtech Saglik Urunleri Anonim Sirketi
Product code
Code OAT
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Istanbul, TR
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.