Cleared Traditional

STRAUMANN TIBRUSH

K111724 · Straumann USA · Dental
Sep 2011
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K111724 is an FDA 510(k) clearance for the STRAUMANN TIBRUSH, a Scaler, Rotary (Class II — Special Controls, product code ELB), submitted by Straumann USA (Andover, US). The FDA issued a Cleared decision on September 12, 2011, 84 days after receiving the submission on June 20, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.4840.

Submission Details

510(k) Number K111724 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2011
Decision Date September 12, 2011
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELB — Scaler, Rotary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4840