Cleared Traditional

TEETHAN 2.0

K161716 · Bts S.P.A. · Dental
Dec 2016
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K161716 is an FDA 510(k) clearance for the TEETHAN 2.0, a Device, Muscle Monitoring (Class II — Special Controls, product code KZM), submitted by Bts S.P.A. (Padova, IT). The FDA issued a Cleared decision on December 21, 2016, 183 days after receiving the submission on June 21, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 890.1375.

Submission Details

510(k) Number K161716 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2016
Decision Date December 21, 2016
Days to Decision 183 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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