ATLANTIS STRAUMANN BONE LEVEL ABUTMENT— 510(k) K130216

Substantially Equivalent

Dentsply Implant

FDA 510(k) clearance K130216 for ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, Substantially Equivalent on 2013-05-01. Applicant: Dentsply Implant.

Clearance details

Applicant: Dentsply Implant
Product code: Code NHA
Advisory panel: Dental
Date received: 2013-01-29
Decision date: 2013-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

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.