Cleared Traditional

PFINGST PRESSURE PASTE (K965026) - FDA 510(k) Clearance

Class I Dental device.

K965026 · Pfingst & Co., Inc. · Dental device
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Feb 1997
Decision
55d
Days
Class 1
Risk

K965026 is an FDA 510(k) clearance for the PFINGST PRESSURE PASTE. Classified as Paper, Articulation (product code EFH), Class I - General Controls.

Submitted by Pfingst & Co., Inc. (South Plainfield,, US). The FDA issued a Cleared decision on February 10, 1997 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6140 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pfingst & Co., Inc. devices

Submission Details

510(k) Number K965026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1996
Decision Date February 10, 1997
Days to Decision 55 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
72d faster than avg
Panel avg: 127d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFH Paper, Articulation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6140
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.