ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT— 510(k) K130408

Substantially Equivalent

Sterngold Dental, LLC

FDA 510(k) clearance K130408 for ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT, Substantially Equivalent on 2013-07-01. Applicant: Sterngold Dental, LLC.

Clearance details

Applicant: Sterngold Dental, LLC
Product code: Code NHA
Advisory panel: Dental
Date received: 2013-02-19
Decision date: 2013-07-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Attleboro, MA, 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.