TatumSurgical/Ball Post for Integrity 5.0, 5.0 x 1.0mm Cuff Height PITI-BP 5.0x1.0mm

GUDID 00083208501081

Ball Post for Integrity 5.0, 5.0 x 1.0mm Cuff Height

Suncoast Dental, Inc

Screw endosteal dental implant, two-piece Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed
Primary Device ID00083208501081
NIH Device Record Key90ba7085-69b6-49bd-ac9e-bf5e16be6a2c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTatumSurgical/Ball Post for Integrity 5.0, 5.0 x 1.0mm Cuff Height
Version Model Number5.0 x 1mm Integrity ball post
Catalog NumberPITI-BP 5.0x1.0mm
Company DUNS078352849
Company NameSuncoast Dental, Inc
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
Emailtatumimplants@verizon.net
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
Phone+1(727)536-4880
Emailtatumcompliance@gmail.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter5 Millimeter
Height1 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Height1 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Height1 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Height1 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Height1 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Height1 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Height1 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Height1 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Height1 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Height1 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Height1 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Height1 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Height1 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Height1 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Height1 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Height1 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100083208501081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEIMPLANT, ENDOSSEOUS, ROOT-FORM
NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-06-10
Device Publish Date2018-07-27

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00083208453212 - Tatum Surgical IP Press Fit Abutment2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 3.0mm Cuff Height
00083208454219 - Tatum Surgical IP Press Fit Abutment2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 4.0mm Cuff Height
00083208455216 - Tatum Surgical IP Press Fit Abutment2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 5.0mm Cuff Height
00083208456213 - Tatum Surgical IP Press Fit Abutment2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 6.0mm Cuff Height
00083208502217 - Tatum Surgical IP Press Fit Abutment2023-01-13 0° (Degree) Shouldered Abutment for 5.0mm Diameter "P" Implants 2.0mm Cuff Height
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