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RMGI Low Viscosity

FDA 510(k)

Class II (US FDA 510(k))

510(k) K123265

by Pulpdent Corporation

Identifiers

510(k) Number
K123265 FDA 510(k)
FDA Product Code
EMA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3275 FDA 510(k)
Regulation Number
872.3275 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Resin-Modified Glass Ionomer (RMGI) Cement, Dental, classified as a Class II medical device. RMGI Low Viscosity combines a bioactive resin matrix with bioactive glass fillers, enabling controlled release of ions into the oral environment. It functions as a restorative material with adhesive properties, designed to bond to tooth structure while providing mechanical support and chemical resistance in dental applications.

Used by dental professionals, RMGI Low Viscosity is supplied as a paste-paste system and sets via three mechanisms: light cure, self-cure resin polymerization, and ionomeric reaction. It is intended for single-use in clinical settings, including as a liner, base, or luting agent in restorative procedures. The device is regulated under FDA 510(k) clearance (K123265) and adheres to the regulatory requirements outlined in 21 CFR 872.3275. No information regarding MRI safety or sterility is provided in the available data.

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: PDF DEC 7 202 PULPDENT CORPORATlION 80 Oakland Street Tel: 617 926 6666 617 ..., RMGI LOW VISCOSITY (K123265) — FDA 510 (k) | Innolitics, Rmgi Low Viscosity 510 (k) FDA Premarket Notification K123265 PULPDENT ..., fda.innolitics.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pulpdent Corporation

Sources (1)

  • FDA 510(k) K123265 24 fields · synced Sep 18, 2026