NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES— 510(k) K971319

Name: FDA 510(k) clearance K971319
Creator: U.S. Food and Drug Administration
Published: 1997-05-22

Substantially Equivalent

Tycom Dental

FDA 510(k) clearance K971319 for NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES, Substantially Equivalent on 1997-05-22. Applicant: Tycom Dental. Device class: 1.

Clearance details

Applicant: Tycom Dental
Product code: Code EKS
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1997-04-10
Decision date: 1997-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EKS

view all

K062856 — TF ROTARY NICKEL TITANIUM FILE2006-12-13
K004031 — NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES2001-03-28
K970649 — HERO 6421997-05-16
K962031 — QUANTEC SERIES 2000 ENDODONTIC FILES1996-06-04
K953604 — SHAPING HEDSTROM N.T.1995-09-28

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.