Cleared Traditional

VERTEX ETCHANT (K010849) - FDA 510(k) Clearance

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

K010849 · Apex Dental Materials, Inc. · Dental device
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Sep 2001
Decision
177d
Days
Class 2
Risk

K010849 is an FDA 510(k) clearance for the VERTEX ETCHANT. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Apex Dental Materials, Inc. (Schaumburg, US). The FDA issued a Cleared decision on September 14, 2001 after a review of 177 days - an extended review cycle.

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 Apex Dental Materials, Inc. devices

Submission Details

510(k) Number K010849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2001
Decision Date September 14, 2001
Days to Decision 177 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
50d slower than avg
Panel avg: 127d · This submission: 177d
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

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