GBR System— 510(k) K233419

Substantially Equivalent

Proimtech Saglik Urunleri Anonim Sirketi

FDA 510(k) clearance K233419 for GBR System, Substantially Equivalent on 2025-01-03. Applicant: Proimtech Saglik Urunleri Anonim Sirketi.

Clearance details

Applicant: Proimtech Saglik Urunleri Anonim Sirketi
Product code: Code DZL
Advisory panel: Dental
Date received: 2023-10-10
Decision date: 2025-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Istanbul, TR

Download summary PDF View on FDA.gov ↗

Adverse events under product code DZL

product code DZL

Injury: 168
Total: 168

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.