Cleared Special

K151646 - ProTech Plus

K151646 is an FDA 510(k) clearance for ProTech Plus, manufactured by Protech Professional Products, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Special 510(k) pathway after a 125-day FDA review.

K151646 · Protech Professional Products, Inc. · Dental device
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Oct 2015
Decision
125d
Days
Class 2
Risk

K151646 is an FDA 510(k) clearance for the ProTech Plus. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Protech Professional Products, Inc. (Boynton Beach, US). The FDA issued a Cleared decision on October 21, 2015 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K151646

510(k) Number K151646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2015
Decision Date October 21, 2015
Days to Decision 125 days
Submission Type Special
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
3d faster than avg
Panel avg: 128d · This submission: 125d
Pathway characteristics
Modification to existing cleared device.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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

Acdm Consulting, LLC
BLIX WINSTON

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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 331
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K151646.
ClearMet
K152051 · Mycone Dental Supply Co., T/A Keystone Industries · Mar 2016
GC Reline II
K153253 · GC America, Inc. · Mar 2016
Denture base resin
K152270 · Korea Engineering Plastics Co., Ltd. · Nov 2015
IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID
K151142 · Wieland Dental + Technik GmbH & Co. KG · Aug 2015
DENTCA DENTURE BASE
K143033 · Dentca, Inc. · Jul 2015
Coating Material
K150511 · Sun Medical Co., Ltd. · May 2015
K151646 · ProTech Plus
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