Elos Accurate® Hybrid Base— 510(k) K242025

Substantially Equivalent

Elos Medtech Pinol A/S

FDA 510(k) clearance K242025 for Elos Accurate® Hybrid Base, Substantially Equivalent on 2024-12-10. Applicant: Elos Medtech Pinol A/S.

Clearance details

Applicant: Elos Medtech Pinol A/S
Product code: Code NHA
Advisory panel: Dental
Date received: 2024-07-11
Decision date: 2024-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goerloese, DK

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.