Cleared Abbreviated

DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM

K122955 · Wright Health Group , Ltd. · Dental
Mar 2013
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K122955 is an FDA 510(k) clearance for the DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM, a Denture, Plastic, Teeth (Class II — Special Controls, product code ELM), submitted by Wright Health Group , Ltd. (Sound Beach, US). The FDA issued a Cleared decision on March 1, 2013, 157 days after receiving the submission on September 25, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3590.

Submission Details

510(k) Number K122955 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2012
Decision Date March 01, 2013
Days to Decision 157 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELM — Denture, Plastic, Teeth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3590