Cleared Traditional

COMPOSITE RESTORATION MATERIAL (K031721) - FDA 510(k) Clearance

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

K031721 · Milton Hodosh, M.D. · Dental device
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Sep 2003
Decision
100d
Days
Class 2
Risk

K031721 is an FDA 510(k) clearance for the COMPOSITE RESTORATION MATERIAL. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Milton Hodosh, M.D. (Providence, US). The FDA issued a Cleared decision on September 11, 2003 after a review of 100 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 Milton Hodosh, M.D. devices

Submission Details

510(k) Number K031721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2003
Decision Date September 11, 2003
Days to Decision 100 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
27d faster than avg
Panel avg: 127d · This submission: 100d
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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K984387 · Dentsply Intl. · Jan 1999