TI-CORE FLOW— 510(k) K101504

Substantially Equivalent

Essential Dental Systems, Inc.

FDA 510(k) clearance K101504 for TI-CORE FLOW, Substantially Equivalent on 2010-10-29. Applicant: Essential Dental Systems, Inc.. Device class: 2.

Clearance details

Applicant: Essential Dental Systems, Inc.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2010-06-01
Decision date: 2010-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Hackensack, NJ, US

Download summary PDF View on FDA.gov ↗

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