Cleared Traditional

RINSENDO (K052271) - FDA 510(k) Clearance

Class I Dental device.

K052271 · Air Techniques, Inc. · Dental device
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May 2006
Decision
280d
Days
Class 1
Risk

K052271 is an FDA 510(k) clearance for the RINSENDO. Classified as Handpiece, Air-powered, Root Canal Irrigation (product code NYL), Class I - General Controls.

Submitted by Air Techniques, Inc. (Hicksville, US). The FDA issued a Cleared decision on May 26, 2006 after a review of 280 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Air Techniques, Inc. devices

Submission Details

510(k) Number K052271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 127d · This submission: 280d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NYL Handpiece, Air-powered, Root Canal Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
Definition To Clean The Root Canal Prior To Filling And Used For Root Canal Irrigation.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.