Cleared Traditional

ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L

K053555 · Guilin Woodpecker Medical Instrument Co., Ltd. · Dental
Aug 2006
Decision
244d
Days
Class 2
Risk

About This 510(k) Submission

K053555 is an FDA 510(k) clearance for the ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L, a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by Guilin Woodpecker Medical Instrument Co., Ltd. (Flintville, US). The FDA issued a Cleared decision on August 21, 2006, 244 days after receiving the submission on December 20, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.4850.

Submission Details

510(k) Number K053555 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2005
Decision Date August 21, 2006
Days to Decision 244 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELC — Scaler, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4850

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