DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM— 510(k) K122955

Name: FDA 510(k) clearance K122955
Creator: U.S. Food and Drug Administration
Published: 2013-03-01

Substantially Equivalent

Wright Health Group , Ltd.

FDA 510(k) clearance K122955 for DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM, Substantially Equivalent on 2013-03-01. Applicant: Wright Health Group , Ltd.. Device class: 2.

Clearance details

Applicant: Wright Health Group , Ltd.
Product code: Code ELM
Device class: Class 2
Regulation: 21 CFR 872.3590
Advisory panel: Dental
Date received: 2012-09-25
Decision date: 2013-03-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Sound Beach, NY, 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.