Cleared Traditional

K153249 - Pulpdent Solo Flowable Composite with MCP

K153249 is an FDA 510(k) clearance for Pulpdent Solo Flowable Composite with MCP, manufactured by Pulpdent Corporation. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K153249 · Pulpdent Corporation · Dental device
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Apr 2016
Decision
144d
Days
Class 2
Risk

K153249 is an FDA 510(k) clearance for the Pulpdent Solo Flowable Composite with MCP. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on April 1, 2016 after a review of 144 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 Pulpdent Corporation devices

FDA 510(k) Submission Details - K153249

510(k) Number K153249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2015
Decision Date April 01, 2016
Days to Decision 144 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
17d slower than avg
Panel avg: 127d · This submission: 144d
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 Consultant

Medtek, LLC
Roger Mastrony

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 784
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K153249.
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everX Posterior
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BRILLIANT EVERGLOW
K152927 · Coltene/Whaledent AG · Apr 2016
BEAUTIFIL II Gingiva
K151700 · Shofu Dental Corporation · Mar 2016
Calcium Bridge
K153191 · Denali Corporation · Feb 2016
VITA VM LC Flow
K152373 · Vita Zahnfabrik H.Rauter GmbH & Co. · Dec 2015