ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACE— 510(k) K063734

Substantially Equivalent

Atlantis Components, Inc.

FDA 510(k) clearance K063734 for ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACE, Substantially Equivalent on 2007-03-02. Applicant: Atlantis Components, Inc..

Clearance details

Applicant: Atlantis Components, Inc.
Product code: Code NHA
Advisory panel: Dental
Date received: 2006-12-18
Decision date: 2007-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skokie, IL, US

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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.