Cleared Special

K151646 - ProTech Plus (FDA 510(k) Clearance)

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K151646 · Protech Professional Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Protech Professional Products, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 127d · This submission: 125d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Peers - EBI Resin, Denture, Relining, Repairing, Rebasing

All 327
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K151646.
LuxCreo Flexible Partial Denture Resin
K253365 · LuxCreo, Inc. · Nov 2025
TERA HARZ Hard Denture (THD-C-500)
K253681 · Graphy, Inc. · Nov 2025
UltraPrint-Dental Denture UV
K253324 · Guangzhou Heygears IMC., Inc. · Nov 2025
Freeprint® denture flex
K252430 · Detax GmbH · Oct 2025
DENTURE SOFT EX (Pink set)
K252035 · Kamemizu Chemical Industry Co., Ltd. · Sep 2025
Flexible Partial Resin
K250302 · Prismatik Dentalcraft, Inc. · Jun 2025