ZMATCH BLOCK— 510(k) K083201

Substantially Equivalent

Dentaim Co., Ltd.

FDA 510(k) clearance K083201 for ZMATCH BLOCK, Substantially Equivalent on 2009-01-26. Applicant: Dentaim Co., Ltd.. Device class: 2.

Clearance details

Applicant: Dentaim Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2008-10-30
Decision date: 2009-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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