FDA device listing

DENMAT PREC JAR

FDA device listing 1735788334 · LLD Care d.o.o.

Key facts

Proprietary names DENMAT PREC JAR
Owner/operator LLD Care d.o.o.
Owner/operator number 10094252
Premarket submissions K040053
Product codes ELW
Device names ELW - Material, Impression
Device class Class II
Classification regulations (21 CFR) 872.3660
Review panels Dental
Registered establishments LLD CARE D.O.O.
Establishment registrations 3042244574
FEI numbers 3042244574
Establishment operations Foreign Exporter
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

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

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

Browse all FDA device listings