Cleared Traditional

K083841 - ADAPTABLE COMPOSITE RESIN RESTORATIVE M...

K083841 is the FDA 510(k) clearance for ADAPTABLE COMPOSITE RESIN RESTORATIVE M... by Dentsply International, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K083841 · Dentsply International, Inc. · Dental device
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Apr 2009
Decision
111d
Days
Class 2
Risk

K083841 is an FDA 510(k) clearance for the ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Dentsply International, Inc. (York, US). The FDA issued a Cleared decision on April 14, 2009 after a review of 111 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 Dentsply International, Inc. devices

Submission Details

510(k) Number K083841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2008
Decision Date April 14, 2009
Days to Decision 111 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 127d · This submission: 111d
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 515
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