Cleared Traditional

RINSENDO

K052271 · Air Techniques, Inc. · Dental

May 2006

Decision

280d

Days

Class 1

Risk

About This 510(k) Submission

K052271 is an FDA 510(k) clearance for the RINSENDO, a Handpiece, Air-powered, Root Canal Irrigation (Class I — General Controls, product code NYL), submitted by Air Techniques, Inc. (Hicksville, US). The FDA issued a Cleared decision on May 26, 2006, 280 days after receiving the submission on August 19, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K052271 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 19, 2005
Decision Date	May 26, 2006
Days to Decision	280 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement

Device Classification

Product Code	NYL — Handpiece, Air-powered, Root Canal Irrigation
Device Class	Class I — General Controls
CFR Regulation	21 CFR 872.4200
Definition	To Clean The Root Canal Prior To Filling And Used For Root Canal Irrigation.