Cleared Traditional

GRINDCARE MEASURE

K113677 · Medotech A/S · Dental
Apr 2012
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K113677 is an FDA 510(k) clearance for the GRINDCARE MEASURE, a Device, Muscle Monitoring (Class II — Special Controls, product code KZM), submitted by Medotech A/S (Westminster, US). The FDA issued a Cleared decision on April 5, 2012, 113 days after receiving the submission on December 14, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 890.1375.

Submission Details

510(k) Number K113677 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2011
Decision Date April 05, 2012
Days to Decision 113 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KZM — Device, Muscle Monitoring
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.1375