DEVICE: Tatum Surgical/One Piece crown and bridge head implant (00083208150111)
Device Identifier (DI) Information
Tatum Surgical/One Piece crown and bridge head implant
One Piece/5.0 x 11CB
In Commercial Distribution
ITO5.0x11CB
Suncoast Dental, Inc
One Piece/5.0 x 11CB
In Commercial Distribution
ITO5.0x11CB
Suncoast Dental, Inc
One Piece Dental Implant 5.0mm diameter and 11mm in length crown and bridge head
Device Characteristics
MR Safe | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Screw endosteal dental implant, one-piece | A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 11 Millimeter |
Outer Diameter: 5 Millimeter |
Device Size Text, specify: One Piece 5.0mm Diameter x 11mm Length CB |
Device Record Status
b7d7a687-779c-49c5-81f5-6abb0eafc7ec
March 29, 2018
2
October 30, 2015
March 29, 2018
2
October 30, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(727)536-4880
tatumimplants@verivon.net
tatumimplants@verivon.net