FILE, PULP CANAL— 510(k) K800293

Name: FDA 510(k) clearance K800293
Creator: U.S. Food and Drug Administration
Published: 1980-02-19

Substantially Equivalent

Ipco Corp.

FDA 510(k) clearance K800293 for FILE, PULP CANAL, Substantially Equivalent on 1980-02-19. Applicant: Ipco Corp.. Device class: 1.

Clearance details

Applicant: Ipco Corp.
Product code: Code EKS
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1980-02-11
Decision date: 1980-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EKS

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K062856 — TF ROTARY NICKEL TITANIUM FILE2006-12-13
K004031 — NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES2001-03-28
K971319 — NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES1997-05-22
K970649 — HERO 6421997-05-16
K962031 — QUANTEC SERIES 2000 ENDODONTIC FILES1996-06-04

More clearances from Ipco Corp.

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K871270 — PERFORM DENTURE BASE RESIN1987-05-29
K850666 — STROBEX ULTRON ELECTROSURGE-DENTAL UNIT1985-05-29
K850906 — TACTILE PLUS DENTAL ELEVATORS1985-04-12
K842836 — SAFE & SOFT MINI PADS & MAXI PADS1984-10-15
K842837 — SAFE & SOFT MAXI SHILEDS1984-10-15

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.