Cleared Traditional

K895259 - PIK POCKET(R), MODEL PP-3 (FDA 510(k) Clearance)

Class I Dental device.

K895259 · Teledyne Water Pik · Dental device
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Nov 1989
Decision
152d
Days
Class 1
Risk

K895259 is an FDA 510(k) clearance for the PIK POCKET(R), MODEL PP-3. Classified as Unit, Oral Irrigation (product code EFS), Class I - General Controls.

Submitted by Teledyne Water Pik (Fort Collins, US). The FDA issued a Cleared decision on November 1, 1989 after a review of 152 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6510 - 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 Teledyne Water Pik devices

Submission Details

510(k) Number K895259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1989
Decision Date November 01, 1989
Days to Decision 152 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 127d · This submission: 152d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFS Unit, Oral Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6510
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.