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RMGI Fill

FDA 510(k)

Class II (US FDA 510(k))

510(k) K130223

by Pulpdent Corporation

Identifiers

510(k) Number
K130223 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)

The RMGI Fill is a resin-modified glass ionomer cement, classified as a dental cement. It combines a bioactive resin matrix with bioactive glass fillers to provide restorative and adhesive properties in dental applications, facilitating bonding to tooth structure and releasing beneficial ions into the oral environment.

This device is supplied as a dual-cure system, enabling both light-cure and self-cure setting mechanisms. It is intended for single-use in dental restorative procedures and is regulated under FDA 510(k) clearance (K130223) as a Class II medical device. No additional sterility or MRI safety information is specified in the provided 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 PULPDENT CORPORATVON - Food and Drug Administration, RMGI FILL (K130223) — FDA 510(k) | Innolitics, PDF PULPDENT CORPORATVON - Food and Drug Administration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pulpdent Corporation

Sources (1)

  • FDA 510(k) K130223 24 fields · synced Sep 18, 2026