EUDAMED device

Prime-Dent Light Cure One-Step Dentin/Enamel Bonding Adhesive

EUDAMED device 00817441022658 · Prime Dental Manufacturing

Key facts

Primary DI 00817441022658
Trade name Prime-Dent Light Cure One-Step Dentin/Enamel Bonding Adhesive
Device name Bonding Agents
Reference or catalog number 006-030
Manufacturer Prime Dental Manufacturing
Manufacturer SRN US-MF-000008807
Risk class Class IIa
EMDN code Q01010104
EMDN description DENTAL BONDING AGENTS
Legislation mdr
Implantable Yes
Sterile No
Single use Yes
Status date Jan 5, 2026

At a glance

  • Yes Matching FDA GUDID record

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About EUDAMED devices

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date:

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