SOLID CORE GUTTA PERCHA CARRIER— 510(k) K905640

Name: FDA 510(k) clearance K905640
Creator: U.S. Food and Drug Administration
Published: 1991-03-05

Substantially Equivalent

The Hygenic Corp.

FDA 510(k) clearance K905640 for SOLID CORE GUTTA PERCHA CARRIER, Substantially Equivalent on 1991-03-05. Applicant: The Hygenic Corp.. Device class: 1.

Clearance details

Applicant: The Hygenic Corp.
Product code: Code EKS
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1990-12-17
Decision date: 1991-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, 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 The Hygenic Corp.

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K954990 — DENTAL DAM1996-01-26
K930764 — ENDO-ICE-PULP TESTER-THERMAL1993-05-27
K905418 — GATES GLIDDEN DRILLS1991-07-25
K911225 — TRAY DOUGH1991-04-17
K900301 — NOVUS BONDING AGENT1990-05-15

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.