Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw— 510(k) K231100
Substantially EquivalentProimtech Saglik Urunleri Anonim Sirketi
FDA 510(k) clearance K231100 for Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw, Substantially Equivalent on 2024-08-23. Applicant: Proimtech Saglik Urunleri Anonim Sirketi.
Clearance details
- Applicant
- Proimtech Saglik Urunleri Anonim Sirketi
- Product code
- Code DZE
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Istanbul, TR
Adverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
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.