Cleared Traditional

K970683 - ZENTIH FLOWABLE COMPOSITE (MULTIPLE)

K970683 is an FDA 510(k) clearance for ZENTIH FLOWABLE COMPOSITE (MULTIPLE), manufactured by Foremost Dental Mfg., Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 141-day FDA review.

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

FDA 510(k) Submission Details - K970683

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
Combination Product No
PCCP Authorized No
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.

EBF Device Classification - Class 2, Special Controls

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 799
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K970683.
CAVIT-LC
K972892 · Espe GmbH & Co. Kg. · Oct 1997
FLOW-RITE
K971594 · Pulpdent Corp. · Sep 1997
BELLEGLASS HP ENAMEL REPAIR MATERIAL
K971762 · Sybron Dental Specialties, Inc. · Sep 1997
PERMALUTE, TRY-IN PASTE
K971898 · Ultradent Products, Inc. · Jun 1997
COMPOGLASS F
K971513 · Ivoclar North America, Inc. · Jun 1997
VARIOLINK II
K971372 · Ivoclar North America, Inc. · May 1997