Establishment registration

Dentsply IH AB

FDA establishment registration 9612468 · MOLNDAL Vastra Gotaland, SE

Key facts

Registration number 9612468
Establishment name Dentsply IH AB
Owner/operator DENTSPLY SIRONA INC
Owner/operator number 2511302
FEI number 3002806429
Address HELIUMGATAN 1
City MOLNDAL Vastra Gotaland
Country SE
Establishment types Repackager/relabeler
Registration valid through 2026
Product codes listed DZE, EIH, EKD, ELZ, EMM, JEY, KCT, LXB, MAH, NDP, NHA
Device classes 1, 2

At a glance

  • 10–99 Device listings
  • 1,000+ UDI devices (GUDID)
  • Current Registration current
  • 1–9 FDA inspections at this FEI

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

About FDA device establishment registrations

Device establishments that manufacture, repackage, relabel or import devices for the U.S. market must register annually with the FDA and list the devices they produce.

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

Browse all FDA device establishment registrations