MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE— 510(k) K111532

Name: FDA 510(k) clearance K111532
Creator: U.S. Food and Drug Administration
Published: 2011-10-07

Substantially Equivalent

Anthogyr Sas

FDA 510(k) clearance K111532 for MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE, Substantially Equivalent on 2011-10-07. Applicant: Anthogyr Sas. Device class: 1.

Clearance details

Applicant: Anthogyr Sas
Product code: Code EGS
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2011-06-03
Decision date: 2011-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sallanches, FR

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.