FDA device listing

STERILE SPIDER SCREW

FDA device listing 1150648709 · HDC S.R.L.

Key facts

Proprietary names STERILE SPIDER SCREW
Owner/operator HDC S.R.L.
Owner/operator number 9077262
Premarket submissions K071851
Product codes DZE
Device names DZE - Implant, Endosseous, Root-Form
Device class Class II
Classification regulations (21 CFR) 872.3640
Review panels Dental
Registered establishments HDC S.R.L.
Establishment registrations 3005728057
FEI numbers 3005728057
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