EUDAMED device

Predicta™

EUDAMED device 00810000525638 · Parkell Inc.

Key facts

Primary DI 00810000525638
Trade name Predicta™
Device name Predicta Cement
Reference or catalog number S630
Manufacturer Parkell Inc.
Manufacturer SRN US-MF-000003761
Risk class Class IIa
EMDN code Q0101010299
EMDN description TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER
Legislation mdd
Implantable No
Sterile No
Single use No
Status date Nov 23, 2022

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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