ISOLIGHT— 510(k) K894059

Substantially Equivalent

Eurodent, Inc.

FDA 510(k) clearance K894059 for ISOLIGHT, Substantially Equivalent on 1989-09-07. Applicant: Eurodent, Inc.. Device class: 1.

Clearance details

Applicant: Eurodent, Inc.
Product code: Code EAZ
Device class: Class 1
Regulation: 21 CFR 872.4630
Advisory panel: Dental
Date received: 1989-06-07
Decision date: 1989-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada J4b 5z5, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code EAZ

K072309 — MICROLUX/BLU2007-11-19
K041614 — MICROLUX DL2005-04-04
K033033 — VIZILITE-BLUE ORAL EXAM KIT2004-11-22
K003995 — SPECULITE/ORALLITE2001-03-16
K926081 — DENTAL LIGHT1994-01-26

More clearances from Eurodent, Inc.

K894058 — ISODENT1989-12-21
K894061 — STUDIO UNO1989-11-21
K894060 — ESSE QUATTRO/ESSE UNO1989-09-07
K790078 — BAR & RIDER, SCREWS, TUBES1979-02-27

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