FDA device listing

DiaPaste

FDA device listing 1784267475 · DiaDent Group International

Key facts

Proprietary names DiaPaste
Owner/operator DiaDent Group International
Owner/operator number 9033762
Premarket submissions K210333
Product codes KIF
Device names KIF - Resin, Root Canal Filling
Device class Class II
Classification regulations (21 CFR) 872.3820
Review panels Dental
Registered establishments DIADENT GROUP INTERNATIONAL
Establishment registrations 9616128
FEI numbers 3010138769
Establishment operations Manufacturer
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