Dmrc Bulk Fill

FDA 510(k)

Class II (US FDA 510(k))

510(k) K151088

Identifiers

510(k) Number: K151088 FDA 510(k)
FDA Product Code: EBF FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 872.3690 FDA 510(k)
Regulation Number: 872.3690 FDA 510(k)
Advisory Committee: Dental FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Dmrc Bulk Fill is a dual-cure polymer-based dental restorative material, functioning as a base or luting agent for posterior composites, core build-ups, and the cementation of crowns, posts, and veneers. It is applied by dental professionals to tooth surfaces pretreated with primers or adhesives.

The Dmrc Bulk Fill is supplied with FDA 510K authorizations and has a product code of EBF. It is classified as a dental device and has been found to be substantially equivalent. The device is available with the reference code K151088.

Frequently asked questions

What is the DMRC Bulk Fill used for?

The DMRC Bulk Fill is used as a base or luting agent for posterior composites, core build-ups, and the cementation of crowns, posts, and veneers.

Is the DMRC Bulk Fill supplied sterile?

The description does not mention sterility, so it is unclear if the DMRC Bulk Fill is supplied sterile or not.

What is the reference code for the DMRC Bulk Fill?

The DMRC Bulk Fill has a reference code of K151088.

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: DMRC Bulk Fill (K151088) — FDA 510 (k) | Innolitics, DMRC Bulk Fill — K151088 · DeviceClearance, DMRC Bulk Fill - BEUDAMED, DMRC Bulk Fill - BEUDAMED

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K151088	Class II	Active

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Manufacturer

Manufacturer: Danville Materials, Llc

Sources (1)

FDA 510(k) K151088 24 fields · synced Sep 25, 2026