Cleared Traditional

PLAK VAK - PV-10 (K864540) - FDA 510(k) Clearance

Class I Dental device.

K864540 · Paul S. Barclay, D.D.S. , Ltd. · Dental device
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Jul 1987
Decision
225d
Days
Class 1
Risk

K864540 is an FDA 510(k) clearance for the PLAK VAK - PV-10. Classified as Unit, Oral Irrigation (product code EFS), Class I - General Controls.

Submitted by Paul S. Barclay, D.D.S. , Ltd. (Chicago, US). The FDA issued a Cleared decision on July 2, 1987 after a review of 225 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 Paul S. Barclay, D.D.S. , Ltd. devices

Submission Details

510(k) Number K864540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1986
Decision Date July 02, 1987
Days to Decision 225 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 127d · This submission: 225d
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.