KLOCKNER DENTAL IMPLANT ABUTMENTS— 510(k) K122988

Name: FDA 510(k) clearance K122988
Creator: U.S. Food and Drug Administration
Published: 2013-07-19

Substantially Equivalent

SOADCO, S.L.

FDA 510(k) clearance K122988 for KLOCKNER DENTAL IMPLANT ABUTMENTS, Substantially Equivalent on 2013-07-19. Applicant: SOADCO, S.L.. Device class: 2.

Clearance details

Applicant: SOADCO, S.L.
Product code: Code NHA
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2012-09-26
Decision date: 2013-07-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Escaldes-Engordany, AD

Download summary PDF View on FDA.gov ↗

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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.