DIFOTI USB 2.0 SYSTEM— 510(k) K043068

Name: FDA 510(k) clearance K043068
Creator: U.S. Food and Drug Administration
Published: 2004-12-29

Substantially Equivalent

Electro-Optical Sciences, Inc.

FDA 510(k) clearance K043068 for DIFOTI USB 2.0 SYSTEM, Substantially Equivalent on 2004-12-29. Applicant: Electro-Optical Sciences, Inc.. Device class: 2.

Clearance details

Applicant: Electro-Optical Sciences, Inc.
Product code: Code NTK
Device class: Class 2
Regulation: 21 CFR 872.1745
Advisory panel: Dental
Date received: 2004-11-08
Decision date: 2004-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvington, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NTK

view all

K261847 — iTero Lumina Pro2026-07-02
K250771 — Primescan 22025-08-29
K240573 — iTero Lumina Pro2024-08-16
K213482 — TIA Tip, Cariosity, Transillumination Accessory Tip2022-04-29
K193659 — iTero Element 5D2020-03-20

More clearances from Electro-Optical Sciences, Inc.

view all

K991098 — DIFOTI SYSTEM1999-06-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.