DEVICE: TatumSurgical/Abutment (Integrity Post) (00083208960307)
Device Identifier (DI) Information
TatumSurgical/Abutment (Integrity Post)
Abutment/6.0mm x 30 degree Integrity Post
Not in Commercial Distribution
PITI-60.30
Suncoast Dental, Inc
Abutment/6.0mm x 30 degree Integrity Post
Not in Commercial Distribution
PITI-60.30
Suncoast Dental, Inc
Integrity Implant Abutment 6.0mm x 30 degree -7mm Height
Device Characteristics
MR Safe | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
55849 | Screw endosteal dental implant, two-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 two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K811923 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Height: 7 Millimeter |
Device Size Text, specify: Integrity Implant Abutment (Post) 6.0mm Diameter x 30°(Degree) Angle x 7mm Height |
Angle: 30 degree |
Outer Diameter: 6 Millimeter |
Device Record Status
8bfe6c9a-aedd-43d6-bbb8-574ff86eeba7
November 18, 2020
4
October 30, 2015
November 18, 2020
4
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