PROCEDURE KIT/ROUTINE DENTAL PROCEDURES— 510(k) K905461

Name: FDA 510(k) clearance K905461
Creator: U.S. Food and Drug Administration
Published: 1991-03-05

Unknown

Angiosystems, Inc.

FDA 510(k) clearance K905461 for PROCEDURE KIT/ROUTINE DENTAL PROCEDURES, Unknown on 1991-03-05. Applicant: Angiosystems, Inc.. Device class: 1.

Clearance details

Applicant: Angiosystems, Inc.
Product code: Code EKS
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1990-12-05
Decision date: 1991-03-05
Decision: Unknown
Clearance type: Traditional
Location: Great Neck, NY, 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
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 Angiosystems, Inc.

view all

K905464 — MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING1991-05-31
K905459 — SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM1991-04-05
K905465 — STERILE DISPOS SURGICAL DRAPE/C-SECTION DRAPE1991-02-11
K905466 — STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE1991-02-11
K905460 — STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY1991-02-06

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.