Cleared Traditional

K864376 - FIBERBOND

K864376 is an FDA 510(k) clearance for FIBERBOND, manufactured by Dentec, Inc.. The device is a Class 1 Dental device with product code DYT cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K864376 · Dentec, Inc. · Dental device
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Apr 1987
Decision
153d
Days
Class 1
Risk

K864376 is an FDA 510(k) clearance for the FIBERBOND. Classified as Maintainer, Space Preformed, Orthodontic (product code DYT), Class I - General Controls.

Submitted by Dentec, Inc. (Roslyn, US). The FDA issued a Cleared decision on April 7, 1987 after a review of 153 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5525 - 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 Dentec, Inc. devices

FDA 510(k) Submission Details - K864376

510(k) Number K864376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1986
Decision Date April 07, 1987
Days to Decision 153 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 127d · This submission: 153d
Pathway characteristics
Predicate-based equivalence.

DYT Device Classification - Class 1, General Controls

Product Code DYT Maintainer, Space Preformed, Orthodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5525
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.