Cleared Traditional

K892861 - DENTAL PIK

K892861 is an FDA 510(k) clearance for DENTAL PIK, manufactured by U.S. Dentek Corp.. The device is a Class 1 Dental device with product code EKS cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K892861 · U.S. Dentek Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K892861

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 128d · This submission: 150d
Pathway characteristics
Predicate-based equivalence.

EKS Device Classification - Class 1, General Controls

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.

Regulatory Peers - EKS File, Pulp Canal, Endodontic

All 30
Devices cleared under the same product code (EKS) and FDA review panel - the closest regulatory comparables to K892861.
VISIONER 21-A
K901037 · J. Morita USA, Inc. · Aug 1990
A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD)
K897195 · A Company, Inc. · May 1990
DE-BOND 200
K883418 · Scheu-Dental · Oct 1989
S-FILE, S-FINDER, S-ENGINE FILE
K892894 · Svenska Dental Instruments AB · May 1989
COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM
K873671 · Coltene, Inc. · Oct 1987
SOLUSET CALCIUM DEMINERALIZING SOLUTION
K864976 · Endo Technic Corp. · Feb 1987
K892861 · DENTAL PIK
Download PDF U.S. Dentek Corp.