UltraPrint-Dental Temp C&B UV— 510(k) K213643

Name: FDA 510(k) clearance K213643
Creator: U.S. Food and Drug Administration
Published: 2022-01-14

Substantially Equivalent

Guangzhou Heygears IMC., Inc.

FDA 510(k) clearance K213643 for UltraPrint-Dental Temp C&B UV, Substantially Equivalent on 2022-01-14. Applicant: Guangzhou Heygears IMC., Inc.. Device class: 2.

Clearance details

Applicant: Guangzhou Heygears IMC., Inc.
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2021-11-18
Decision date: 2022-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

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