Cleared Traditional

K211721 - PS System (FDA 510(k) Clearance)

Class I Dental device.

K211721 · Inter-Med, Inc. · Dental device
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Dec 2021
Decision
181d
Days
Class 1
Risk

K211721 is an FDA 510(k) clearance for the PS System. Classified as Handpiece, Air-powered, Root Canal Irrigation (product code NYL), Class I - General Controls.

Submitted by Inter-Med, Inc. (Racine, US). The FDA issued a Cleared decision on December 2, 2021 after a review of 181 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 Inter-Med, Inc. devices

Submission Details

510(k) Number K211721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2021
Decision Date December 02, 2021
Days to Decision 181 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 127d · This submission: 181d
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.