STUDIO UNO— 510(k) K894061

Substantially Equivalent

Eurodent, Inc.

FDA 510(k) clearance K894061 for STUDIO UNO, Substantially Equivalent on 1989-11-21. Applicant: Eurodent, Inc.. Device class: 1.

Clearance details

Applicant: Eurodent, Inc.
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 1989-06-07
Decision date: 1989-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada J4b 5z5, CA

Download summary PDF View on FDA.gov ↗

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More clearances from Eurodent, Inc.

K894058 — ISODENT1989-12-21
K894059 — ISOLIGHT1989-09-07
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.