Cleared Traditional

K870765 - CANNULATED INSTRUMENT CLEANERS

K870765 is an FDA 510(k) clearance for CANNULATED INSTRUMENT CLEANERS, manufactured by Treace Medical, Inc.. The device is a Class 1 Dental device with product code EKW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K870765 · Treace Medical, Inc. · Dental device
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May 1987
Decision
90d
Days
Class 1
Risk

K870765 is an FDA 510(k) clearance for the CANNULATED INSTRUMENT CLEANERS. Classified as Broach, Endodontic (product code EKW), Class I - General Controls.

Submitted by Treace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on May 27, 1987 after a review of 90 days - within the typical 510(k) review window.

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 Treace Medical, Inc. devices

FDA 510(k) Submission Details - K870765

510(k) Number K870765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1987
Decision Date May 27, 1987
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

EKW Device Classification - Class 1, General Controls

Product Code EKW Broach, 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.