UDI device identifier

One Piece Dental Implant Small Ball Head ITO 3.0x25mm (SB)

UDI device identifier 00083208230257 · Suncoast Dental, Inc

Key facts

Primary DI 00083208230257
Brand name One Piece Dental Implant Small Ball Head
Version or model ITO 3.0x25mm (SB)
Catalog number ITO 3.0x25mm (SB)
Company Suncoast Dental, Inc
DUNS number 078352849
Product code DZE
GMDN term Screw endosteal dental implant, one-piece
Premarket submission K811923
Device class Class II
Single use Yes
Packaged sterile No
Implantable Yes
Publish date Jun 12, 2019
Version date Jun 19, 2020
Description One Piece Dental Implant 3.0 mm diameter and 25mm length Small Ball Head

At a glance

  • None MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 1,000+ GUDID devices with this product code

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

About UDI device identifiers (GUDID)

The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.

Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date:

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