ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA— 510(k) K200676

Name: FDA 510(k) clearance K200676
Creator: U.S. Food and Drug Administration
Published: 2020-07-08

Substantially Equivalent

Zirkonzahn Srl

FDA 510(k) clearance K200676 for ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA, Substantially Equivalent on 2020-07-08. Applicant: Zirkonzahn Srl. Device class: 2.

Clearance details

Applicant: Zirkonzahn Srl
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2020-03-16
Decision date: 2020-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gais, IT

Download summary PDF View on FDA.gov ↗

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