Cleared Traditional

K921354 - BLUNT TIP IRRIGATION NEEDLES (FDA 510(k) Clearance)

Class I Dental device.

K921354 · Innovators, Inc. · Dental device
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Sep 1992
Decision
189d
Days
Class 1
Risk

K921354 is an FDA 510(k) clearance for the BLUNT TIP IRRIGATION NEEDLES. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by Innovators, Inc. (Jefferson City, US). The FDA issued a Cleared decision on September 25, 1992 after a review of 189 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Innovators, Inc. devices

Submission Details

510(k) Number K921354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1992
Decision Date September 25, 1992
Days to Decision 189 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
62d slower than avg
Panel avg: 127d · This submission: 189d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKJ Burnisher, Operative
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.