Cleared Traditional

PIEZO BONE SURGERY

K111290 · Guilin Woodpecker Medical Instrument Co., Ltd. · Dental
Nov 2011
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K111290 is an FDA 510(k) clearance for the PIEZO BONE SURGERY, a Drill, Bone, Powered (Class II — Special Controls, product code DZI), submitted by Guilin Woodpecker Medical Instrument Co., Ltd. (Echo, US). The FDA issued a Cleared decision on November 18, 2011, 196 days after receiving the submission on May 6, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K111290 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2011
Decision Date November 18, 2011
Days to Decision 196 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZI — Drill, Bone, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120