UDI device identifier
Tatum Surgical/One Piece small ball head implant One Piece/7.0x14SB
UDI device identifier 00083208270147 · Suncoast Dental, Inc
Key facts
| Primary DI | 00083208270147 |
|---|---|
| Brand name | Tatum Surgical/One Piece small ball head implant |
| Version or model | One Piece/7.0x14SB |
| Catalog number | ITO7.0x14SB |
| 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 | Jul 18, 2018 |
| Version date | Jun 12, 2019 |
| Description | One Piece Dental Implant 7.0mm diameter and 14mm in 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: