SHAPING HEDSTROM N.T.— 510(k) K953604

Name: FDA 510(k) clearance K953604
Creator: U.S. Food and Drug Administration
Published: 1995-09-28

Substantially Equivalent

Sybron Dental Specialties, Inc.

FDA 510(k) clearance K953604 for SHAPING HEDSTROM N.T., Substantially Equivalent on 1995-09-28. Applicant: Sybron Dental Specialties, Inc.. Device class: 1.

Clearance details

Applicant: Sybron Dental Specialties, Inc.
Product code: Code EKS
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1995-08-02
Decision date: 1995-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendora, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EKS

product code EKS

Malfunction: 1,949
Total: 1,949

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.