DENTAL IMPLANT, DENTAL ABUTMENT, ABUTMENT SCREW, COVER SCREW, HEALING ABUTMENT— 510(k) K070184

Substantially Equivalent

Ospol AB

FDA 510(k) clearance K070184 for DENTAL IMPLANT, DENTAL ABUTMENT, ABUTMENT SCREW, COVER SCREW, HEALING ABUTMENT, Substantially Equivalent on 2008-03-24. Applicant: Ospol AB.

Clearance details

Applicant: Ospol AB
Product code: Code DZE
Advisory panel: Dental
Date received: 2007-01-19
Decision date: 2008-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malmo, SE

Download summary PDF View on FDA.gov ↗

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, 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.