Cleared Traditional

ZENTIH FLOWABLE COMPOSITE (MULTIPLE) (K970683) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K970683 · Foremost Dental Mfg., Inc. · Dental device
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Jul 1997
Decision
141d
Days
Class 2
Risk

K970683 is an FDA 510(k) clearance for the ZENTIH FLOWABLE COMPOSITE (MULTIPLE). Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Foremost Dental Mfg., Inc. (Englewood, US). The FDA issued a Cleared decision on July 15, 1997 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Foremost Dental Mfg., Inc. devices

Submission Details

510(k) Number K970683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1997
Decision Date July 15, 1997
Days to Decision 141 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
14d slower than avg
Panel avg: 127d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 195
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K945769 · Dentsply Intl. · Dec 1994