K231100
- 510(k) number
- K231100
- Device name
- Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw
- Applicant
- Proimtech Saglik Urunleri Anonim Sirketi TR
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2024-08-23
- Date received
- 2023-04-18
- 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: K231100.pdf
Official FDA record: K231100
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.