Cleared Traditional

DENTAL PIK (K892861) - FDA 510(k) Clearance

Class I Dental device.

K892861 · U.S. Dentek Corp. · Dental device
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Sep 1989
Decision
150d
Days
Class 1
Risk

K892861 is an FDA 510(k) clearance for the DENTAL PIK. Classified as File, Pulp Canal, Endodontic (product code EKS), Class I - General Controls.

Submitted by U.S. Dentek Corp. (Novato, US). The FDA issued a Cleared decision on September 15, 1989 after a review of 150 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 U.S. Dentek Corp. devices

Submission Details

510(k) Number K892861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1989
Decision Date September 15, 1989
Days to Decision 150 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 127d · This submission: 150d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKS File, Pulp Canal, Endodontic
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.