P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS— 510(k) K080239

Substantially Equivalent

Straumann Manufacturing, Inc.

FDA 510(k) clearance K080239 for P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS, Substantially Equivalent on 2008-04-30. Applicant: Straumann Manufacturing, Inc..

Clearance details

Applicant: Straumann Manufacturing, Inc.
Product code: Code NHA
Advisory panel: Dental
Date received: 2008-01-31
Decision date: 2008-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, 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.