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PMMA Block

FDA 510(k)

Class II (US FDA 510(k))

510(k) K201683

by Huge Dental Material Co., Ltd.

Identifiers

510(k) Number
K201683 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 PMMA Block is a dental polymer material used for industrial and commercial applications. It is produced by combining methyl methacrylate monomers with various ingredients to create a strong and lightweight material.

This device is identified under K-number K201683 and has received FDA 510(k) clearance. It is classified under the dental product code EBG.

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: Polymethylmethacrylat – Wikipedia, Dental Pmma Blocks, Dental Pmma Disc | HUGE Dental, Was ist PMMA? Alles über Eigenschaften & Anwendungen, PMMA Blocks — HUGE Dental, Multilayer PMMA BLOCK, Multilayer PMMA Disc | HUGE Dental

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Huge Dental Material Co., Ltd.

Sources (1)

  • FDA 510(k) K201683 24 fields · synced Sep 22, 2026