DX. Bond V Dental Bonding Adhesive— 510(k) K232978

Name: FDA 510(k) clearance K232978
Creator: U.S. Food and Drug Administration
Published: 2023-09-22

Substantially Equivalent

Sino-Dentex Co., Ltd.

FDA 510(k) clearance K232978 for DX. Bond V Dental Bonding Adhesive, Substantially Equivalent on 2023-09-22. Applicant: Sino-Dentex Co., Ltd.. Device class: 2.

Clearance details

Applicant: Sino-Dentex Co., Ltd.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2023-09-21
Decision date: 2023-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint Paul, MN, 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.