EUDAMED device

Prime-Dent Light Cure Pit and Fissure Sealant

EUDAMED device 00817441023211 · Prime Dental Manufacturing

Key facts

Primary DI 00817441023211
Trade name Prime-Dent Light Cure Pit and Fissure Sealant
Device name Dental Pit and Fissure Sealants and Liners
Reference or catalog number 007-022
Model TF10
Manufacturer Prime Dental Manufacturing
Manufacturer SRN US-MF-000008807
Risk class Class IIa
EMDN code Q01010199
EMDN description DENTAL RESTORATION DEVICES - OTHER
Legislation mdr
Implantable Yes
Sterile No
Single use Yes
Status date Jan 6, 2026

At a glance

  • No 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:

Browse all EUDAMED devices