Cleared Traditional

K052271 - RINSENDO

K052271 is an FDA 510(k) clearance for RINSENDO, manufactured by Air Techniques, Inc.. The device is a Class 1 Dental device with product code NYL cleared through the Traditional 510(k) pathway after a 280-day FDA review.

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

FDA 510(k) Submission Details - K052271

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 127d · This submission: 280d
Pathway characteristics
Predicate-based equivalence.

NYL Device Classification - Class 1, General Controls

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.