FILE TYPE H (HEDSTROEM) ENDODONTIC— 510(k) K823685

Name: FDA 510(k) clearance K823685
Creator: U.S. Food and Drug Administration
Published: 1982-12-28

Substantially Equivalent

United Dental Mfg., Inc.

FDA 510(k) clearance K823685 for FILE TYPE H (HEDSTROEM) ENDODONTIC, Substantially Equivalent on 1982-12-28. Applicant: United Dental Mfg., Inc.. Device class: 1.

Clearance details

Applicant: United Dental Mfg., Inc.
Product code: Code EKS
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1982-12-07
Decision date: 1982-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from United Dental Mfg., Inc.

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K843017 — ABSORBENT ENDODONTIC POINT1985-01-09
K823684 — FILE TYPE K ENDODONTIC1982-12-28
K823686 — REAMER TYPE K ENDODONTIC1982-12-28
K812886 — ENDODONTIC PAPER POINTS1981-11-16

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.