UDI device identifier

Tatum Surgical/One Piece Crown and Bridge head implant One Piece/8.0x17CB

UDI device identifier 00083208180170 · Suncoast Dental, Inc

Key facts

Primary DI 00083208180170
Brand name Tatum Surgical/One Piece Crown and Bridge head implant
Version or model One Piece/8.0x17CB
Catalog number ITO8.0x17CB
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 Aug 28, 2018
Version date Jun 1, 2020
Description One Piece Dental Implant 8.0mm diameter and 17mm in length crown and bridge 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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