Resin for Temporary Crown & Bridge— 510(k) K180657

Name: FDA 510(k) clearance K180657
Creator: U.S. Food and Drug Administration
Published: 2018-12-07

Substantially Equivalent

Dentis Co., Ltd.

FDA 510(k) clearance K180657 for Resin for Temporary Crown & Bridge, Substantially Equivalent on 2018-12-07. Applicant: Dentis Co., Ltd.. Device class: 2.

Clearance details

Applicant: Dentis Co., Ltd.
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2018-03-13
Decision date: 2018-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu, 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.