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Harvest Dental Polymer Blocks

FDA 510(k)

Class II (US FDA 510(k))

510(k) K180578

by Harvest Dental Products, LLC

Identifiers

510(k) Number
K180578 FDA 510(k)
FDA Product Code
EBG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3770 FDA 510(k)
Regulation Number
872.3770 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Harvest Dental Polymer Blocks are Dental Polymer Blocks (Product Code EBG) designed for use in dental laboratories. These blocks are composed of polymethyl methacrylate (PMMA) and serve as a base material for fabricating temporary crowns, bridges, or other provisional restorations, providing a durable and biocompatible foundation for dental prosthetics.

These polymer blocks are supplied in a non-sterile, reusable format for laboratory use. They are intended for use in dental laboratories under controlled conditions and are regulated under the FDA’s 510(k) clearance (K180578) as a dental device. The blocks are not intended for direct patient use but rather as a substrate for further processing and shaping by dental technicians. No MRI safety or sterility requirements are specified in the regulatory data.

Frequently asked questions

Are these polymer blocks meant for direct patient application, or are they used as a base material in a dental lab?

These blocks are not intended for direct patient use. Instead, they serve as a base material for dental technicians in laboratories to fabricate temporary crowns, bridges, or provisional restorations. The polymer blocks require further processing, shaping, and curing before being used in patient care.

How are the Harvest Dental Polymer Blocks supplied, and can they be reused?

The blocks are supplied in a non-sterile, reusable format specifically for dental laboratory use. Since they are designed for controlled lab environments, they are meant to be processed multiple times by technicians before eventual use in patient restorations.

What material are these polymer blocks made from, and why does that matter for dental applications?

The blocks are composed of polymethyl methacrylate (PMMA), a material commonly used in dental prosthetics due to its durability and biocompatibility. PMMA provides a stable foundation for temporary restorations, ensuring they can withstand the demands of provisional dental work while minimizing patient irritation.

Are there any special storage requirements for these polymer blocks?

The provided data does not specify any special storage conditions beyond standard laboratory practices for dental materials. Since they are reusable and non-sterile, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain their integrity for repeated use.

What regulatory pathway was followed for FDA clearance of these polymer blocks?

The Harvest Dental Polymer Blocks received FDA 510(k) clearance (K180578) under the Traditional 510(k) Review pathway, determined to be substantially equivalent to a predicate device. The review was conducted by the Dental (DE) Advisory Committee, and the decision was made in December 2018.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Harvest Dental Products, K180578 - Harvest Dental Polymer Blocks | FDA 510 (k), Products - HarvestDental, Harvest Dental Polymer Blocks (K180578) — FDA 510(k) | Innolitics, Harvest Dental Polymer Blocks (Zcad, Aurora)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Harvest Dental Products, LLC

Sources (1)

  • FDA 510(k) K180578 24 fields · synced Sep 19, 2026