SURGmatic S15 L Pro— 510(k) K213139

Name: FDA 510(k) clearance K213139
Creator: U.S. Food and Drug Administration
Published: 2021-12-21

Substantially Equivalent

Kavo Dental GmbH

FDA 510(k) clearance K213139 for SURGmatic S15 L Pro, Substantially Equivalent on 2021-12-21. Applicant: Kavo Dental GmbH. Device class: 1.

Clearance details

Applicant: Kavo Dental GmbH
Product code: Code EGS
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2021-09-27
Decision date: 2021-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Biberach, DE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EGS

product code EGS

Injury: 356
Malfunction: 759
Total: 1,115

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.