K233419
- 510(k) number
- K233419
- Device name
- GBR System
- Applicant
- Proimtech Saglik Urunleri Anonim Sirketi TR
- Product code
- DZL — Screw, Fixation, Intraosseous
- Decision date
- 2025-01-03
- Date received
- 2023-10-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K233419.pdf
Official FDA record: K233419
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.