ANGLED TAPERED ABUTMENT— 510(k) K111853

Substantially Equivalent

Zimmer Dental, Inc.

FDA 510(k) clearance K111853 for ANGLED TAPERED ABUTMENT, Substantially Equivalent on 2011-12-08. Applicant: Zimmer Dental, Inc..

Clearance details

Applicant: Zimmer Dental, Inc.
Product code: Code NHA
Advisory panel: Dental
Date received: 2011-06-29
Decision date: 2011-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, 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.