Tatum Surgical-Integrity Implant 4.0x17mm, Bone Level ITI-B 4.0 x 17mm

GUDID 00083208494079

Integrity Dental Implant 4.0mm in diameter and 17mm in length, bone level

Suncoast Dental, Inc

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece
Primary Device ID00083208494079
NIH Device Record Key06333ec7-5d3d-4c8b-9f99-ef7db3ea6e3b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTatum Surgical-Integrity Implant 4.0x17mm, Bone Level
Version Model NumberITI-B 4.0x17
Catalog NumberITI-B 4.0 x 17mm
Company DUNS078352849
Company NameSuncoast Dental, Inc
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com
Phone+1 (727) 536-4880
Emailtatumcompliance@gmail.com

Device Dimensions

Outer Diameter4 Millimeter
Height17 Millimeter
Outer Diameter4 Millimeter
Height17 Millimeter
Outer Diameter4 Millimeter
Height17 Millimeter
Outer Diameter4 Millimeter
Height17 Millimeter
Outer Diameter4 Millimeter
Height17 Millimeter
Outer Diameter4 Millimeter
Height17 Millimeter
Outer Diameter4 Millimeter
Height17 Millimeter
Outer Diameter4 Millimeter
Height17 Millimeter
Outer Diameter4 Millimeter
Height17 Millimeter
Outer Diameter4 Millimeter
Height17 Millimeter
Outer Diameter4 Millimeter
Height17 Millimeter
Outer Diameter4 Millimeter
Height17 Millimeter
Outer Diameter4 Millimeter
Height17 Millimeter
Outer Diameter4 Millimeter
Height17 Millimeter
Outer Diameter4 Millimeter
Height17 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100083208494079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00083208494079]

Moist Heat or Steam Sterilization


[00083208494079]

Moist Heat or Steam Sterilization


[00083208494079]

Moist Heat or Steam Sterilization


[00083208494079]

Moist Heat or Steam Sterilization


[00083208494079]

Moist Heat or Steam Sterilization


[00083208494079]

Moist Heat or Steam Sterilization


[00083208494079]

Moist Heat or Steam Sterilization


[00083208494079]

Moist Heat or Steam Sterilization


[00083208494079]

Moist Heat or Steam Sterilization


[00083208494079]

Moist Heat or Steam Sterilization


[00083208494079]

Moist Heat or Steam Sterilization


[00083208494079]

Moist Heat or Steam Sterilization


[00083208494079]

Moist Heat or Steam Sterilization


[00083208494079]

Moist Heat or Steam Sterilization


[00083208494079]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-07-22
Device Publish Date2020-08-24

Devices Manufactured by Suncoast Dental, Inc

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00083208494574 - Tatum Surgical-Integrity Implant 4.5x17mm, Bone Level2021-07-22 Integrity Dental Implant 4.5mm in diameter and 17mm in length, bone level
00083208494000 - Tatum Surgical-Integrity Implant 4.0x20mm, Bone Level2021-07-22 Integrity Dental Implant 4.0mm in diameter and 20mm in length, bone level
00083208494079 - Tatum Surgical-Integrity Implant 4.0x17mm, Bone Level2021-07-22Integrity Dental Implant 4.0mm in diameter and 17mm in length, bone level
00083208494079 - Tatum Surgical-Integrity Implant 4.0x17mm, Bone Level2021-07-22 Integrity Dental Implant 4.0mm in diameter and 17mm in length, bone level
00083208494512 - Tatum Surgical-Integrity Implant 4.5x11mm, Bone Level2021-07-22 Integrity Dental Implant 4.5mm in diameter and 11mm in length, bone level
00083208409370 - Tatum Surgical/Integrity Implant2021-07-14 Integrity Dental Implant 3.7mm in diameter and 9mm in length
00083208409400 - Tatum Surgical/Integrity Implant2021-07-14 Integrity Dental Implant 4.0mm in diameter and 9mm in length
00083208409455 - Tatum Surgical/Integrity Implant2021-07-14 Integrity Dental Implant 4.5mm in diameter and 9mm in length

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